Boston Scientific OverStitch Suture Cinch Recall, What Patients and Providers Need to Know — Recall ID No. RA-82395

Boston Scientific is pulling specific lots of its OverStitch Suture Cinch and Suture Cinch–Long off the market. If you had an endoscopic sleeve gastroplasty, a defect closure, or another suturing procedure recently — this recall might involve the exact device your doctor used. Here’s what actually happened, and what it means for you.

Boston Scientific OverStitch Suture Cinch Recall — Key Facts

Field	Detail
Manufacturer	Boston Scientific Corporation
Products Affected	OverStitch™ Suture Cinch (Model M00505540) and Suture Cinch–Long (Model M00505550)
Used With	OverStitch Endoscopic Suturing System, OverStitch NXT Endoscopic Suturing System, X-Tack Endoscopic HeliX Tacking System
Problem	Cinch may fail to deploy the implant and/or fail to cut the suture during use
Detectable Before Use?	No — the defect only shows up when the device is activated mid-procedure
Recall Class	Type II (Health Canada) — UNVERIFIED for FDA classification, see note below
Recall Initiated	July 14, 2026
Recall Published	July 23, 2026
Identification Number	RA-82395 (Health Canada)
Lawsuit Filed?	No — UNVERIFIED, no litigation located as of research date
Settlement Amount	Not applicable — no settlement exists
Last Updated	September 4, 2026

Who Is Boston Scientific and Why Was This Device Recalled?

Boston Scientific makes the OverStitch system used by gastroenterologists to place full-thickness sutures through an endoscope — no incision required. The Suture Cinch is the small accessory that locks and cuts the suture once it’s placed. It’s not a standalone product; it’s a component surgeons load mid-procedure, which is exactly why a hidden defect in it is hard to catch. You can’t tell it’s faulty by looking at it. It fails at the moment it matters most — when the surgeon tries to deploy it.

What Happened With the OverStitch Suture Cinch Between 2024 and 2026?

Boston Scientific told regulators the Suture Cinch and Suture Cinch–Long may fail to deploy the cinch implant, fail to cut the suture as intended, or both. The company says the issue can’t be caught through routine pre-use inspection — it only becomes apparent once a physician activates the device during an actual procedure. That’s a meaningful distinction from a typical packaging or sterility recall. Nobody checking inventory on a shelf would have caught this.

Eighteen specific lots are named in the recall: six lots of Suture Cinch–Long (model M00505550) and twelve lots of the standard OverStitch Suture Cinch (model M00505540). Health Canada classified this as a Type II recall — its middle-severity tier, reserved for issues that could cause temporary or reversible harm.

This isn’t Boston Scientific’s first suture-accessory recall in recent years. In June 2024, the company pulled lots of its Capio SLIM Suture Capturing Device for a similar reason — the device wasn’t reliably catching the suture needle during use. Two suture-related accessory recalls in about two years, both tied to the mechanism failing at the moment of deployment rather than in storage, is a pattern worth knowing about if you or a loved one had a procedure involving either device.

That pattern matters because it points to something structural, not a one-off manufacturing slip. If a cinch fails mid-procedure, the surgeon isn’t left with a shelf problem — they’re left improvising a fix on a patient who’s already under anesthesia.

Are You Affected by the OverStitch Suture Cinch Recall?

Here’s exactly how to know if this involves you or your practice.

This recall reaches:

• Patients who underwent an endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), or another endoscopic defect-closure procedure where a Suture Cinch or Suture Cinch–Long was used
• Gastroenterologists and bariatric surgeons who performed those procedures using the affected lots
• Hospitals and endoscopy centers currently holding inventory of the 18 recalled lots
• Patients who experienced an unexpected complication, revision surgery, or additional intervention during a suturing procedure since 2024

This does not currently include:

• Anyone who had a procedure using the OverStitch handle or needle driver components alone, without a Suture Cinch from the affected lots
• Patients treated with OverStitch systems from lots not named in the recall notice

If your procedure went smoothly with no complications, you likely have nothing to act on beyond asking your provider whether your specific device lot was affected — but it’s worth asking, since the defect isn’t something you or your doctor would have seen coming.

OverStitch Suture Cinch Patients Outside Canada — Are You Still Covered?

Boston Scientific distributes globally, and Health Canada’s notice covers devices sold in Canada specifically. Whether the same lots reached hospitals in the United States, and whether the FDA has opened its own recall record, is something I could not confirm as of this writing — flagged UNVERIFIED above. If you’re in the U.S. and had a suturing procedure in this window, the fastest way to know is to ask your provider directly whether the device used carried one of the 18 recalled lot numbers.

Not sure if your procedure involved a recalled OverStitch Suture Cinch lot? A free consultation with a product liability attorney can help you find out before you decide whether to pursue anything further.

Is There Money in This — What Can You Actually Get?

Short answer: there’s no settlement, no claim form, and no payout to apply for right now. This is a device recall, not a resolved lawsuit. If you saw headlines suggesting otherwise, that’s not accurate as of this writing.

What does exist is the standard product liability path that opens up any time a defective medical device causes harm. If you had a Suture Cinch fail during your procedure and it led to a longer surgery, a revision procedure, an unexpected complication, or additional medical costs, you may have grounds for an individual claim against Boston Scientific — separate from any recall notice. That’s a case-by-case legal question, not something a recall notice answers on its own.

Honestly, the recall itself doesn’t hand you anything. The recall tells you the company found a problem and is pulling the product. Whether you have a claim depends entirely on what actually happened during your procedure.

What Should You Do Right Now?

1. Ask your gastroenterologist or the facility where you had your procedure whether a Suture Cinch or Suture Cinch–Long was used, and whether it came from one of the 18 recalled lots (models M00505540 or M00505550).
2. Pull your own records now — operative reports, discharge summaries, and any notes about complications, revision procedures, or extended procedure time.
3. Document any additional treatment, follow-up surgery, or medical costs connected to a device failure during your procedure.
4. If you’re a provider or facility, quarantine any remaining affected inventory and contact Boston Scientific directly rather than continuing to use the named lots.
5. If you experienced a complication, report it to the FDA’s MedWatch program in addition to your provider’s internal reporting.
6. Talk to a product liability attorney if you had any complication during a procedure involving this device — there’s no deadline pressure the way there would be with a settlement, but device-related injury claims are still subject to standard statutes of limitations that vary by state.

Boston Scientific OverStitch Suture Cinch — Full Timeline

Milestone	Date
Capio SLIM Suture Capturing Device recall (related prior incident)	June 27, 2024
Suture Cinch recall initiated by Boston Scientific	July 14, 2026
Health Canada recall notice published	July 23, 2026
U.S. FDA recall record	UNVERIFIED — not located as of research date
Lawsuit or class action filed	UNVERIFIED — none located as of research date
Next scheduled action	UNVERIFIED — no further updates published as of research date

Boston Scientific OverStitch Recall — Frequently Asked Questions, Recall ID No. RA-82395

Is there a lawsuit against Boston Scientific over the OverStitch Suture Cinch recall right now? 

Not that’s been publicly confirmed. This is currently a manufacturer-initiated recall reported to Health Canada, not litigation. Individual patients who were harmed can still pursue their own product liability claims regardless of whether a class action ever forms.

Do I need to do anything right now if I had an endoscopic suturing procedure?

 Only if you’re unsure whether your device came from one of the 18 recalled lots (M00505540 or M00505550). Ask your provider. If your procedure had no complications, there’s no urgent action required.

What does “Type II” recall mean for this Boston Scientific device?

 Health Canada’s Type II classification means the agency believes the defect could cause temporary or reversible health problems — a step below the most serious category, but still significant enough to warrant pulling product from the market.

Can I file my own lawsuit against Boston Scientific if I was injured during a procedure using this device? 

Yes. Individual product liability claims don’t require a class action or a recall lawsuit to exist first. If a Suture Cinch failure caused you harm, you can consult an attorney about an individual claim.

How will I find out if a class action forms against Boston Scientific over this recall?

 There’s no way to predict that. If litigation develops, it would typically show up first in court filings and legal news coverage, not in the recall notice itself.

Is the OverStitch NXT system also affected by this recall? 

The recall covers the Suture Cinch and Suture Cinch–Long accessories, which are used with the original OverStitch system, OverStitch NXT, and the X-Tack Endoscopic HeliX Tacking System. The recall is about the cinch component specifically, not the entire suturing platform.

Has anyone reported an injury connected to this specific recall?

 The Health Canada notice describing this recall doesn’t include injury or death figures. That’s marked UNVERIFIED in this article rather than estimated.

What should hospitals and endoscopy centers do with existing Suture Cinch inventory?

 Boston Scientific’s typical process for this kind of action is to ask facilities to quarantine affected lots and contact the company directly. Check your specific lot numbers against models M00505540 and M00505550 before further use.

Sources Used in This Boston Scientific OverStitch Article

• Health Canada — OverStitch™ Suture Cinch and Suture Cinch–Long Recall Notice, published July 23, 2026: https://recalls-rappels.canada.ca/en/alert-recall/overstitchtm-suture-cinch-and-suture-cinch-long
• Health Canada — Capio™ SLIM Suture Capturing Device Recall Notice (related prior recall), June 27, 2024: https://recalls-rappels.canada.ca/en/alert-recall/capiotm-slim-suture-capturing-device
• Boston Scientific — OverStitch™ Endoscopic Suturing System product page: https://www.bostonscientific.com/en-US/products/endoscopic-closure/overstitch-endoscopic-suturing-system.html

Researched and written by Israr Ahmad, legal content researcher and founder of AllAboutLawyer.com. All facts verified against the Health Canada recall notice (RA-82395) and the related Capio SLIM recall notice, as of September 4, 2026. No matching U.S. FDA recall record or lawsuit filing was located as of this date — those fields are marked UNVERIFIED rather than assumed. Last Updated: September 4, 2026.

This article is for informational purposes only and does not constitute legal or medical advice. Laws vary by state and individual circumstances differ. For advice about your specific situation, consult a qualified attorney or your healthcare provider.

Internal linking — flagged, not filled

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• A general “medical device recall — your legal rights” explainer, if you have one live
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Fill these in only once you’ve verified the URL loads and returns a 200 — don’t force a link to a page that might not actually be live.