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Boston Scientific Corporation recalls

Every recall we track for Boston Scientific Corporation — 573 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 18 are rated “stop using now”.

573recalls

Recalls per year, by danger level

Recalls from Boston Scientific Corporation fell by more than half in 2025 (72, down from 148 in 2024). 3% rated “stop using now”.

2017: 47 recalls — 2 stop using now, 20 use caution, 20 lower risk, 5 not yet rated4720172018: 25 recalls — 11 use caution, 13 lower risk, 1 not yet rated2520182019: 34 recalls — 11 use caution, 23 lower risk3420192020: 85 recalls — 3 stop using now, 26 use caution, 39 lower risk, 17 not yet rated8520202021: 66 recalls — 4 stop using now, 16 use caution, 40 lower risk, 6 not yet rated6620212022: 21 recalls — 2 stop using now, 7 use caution, 12 lower risk2120222023: 33 recalls — 1 stop using now, 9 use caution, 22 lower risk, 1 not yet rated3320232024: 148 recalls — 5 stop using now, 78 use caution, 65 lower risk14820242025: 72 recalls — 28 use caution, 43 lower risk, 1 not yet rated7220252026 (to date): 42 recalls — 1 stop using now, 13 use caution, 27 lower risk, 1 not yet rated422026to date

All FDA recall records for Boston Scientific Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Boston Scientific Corporation, by danger level
YearStop using nowUse cautionLower riskNot yet ratedTotal
201722020547
201801113125
201901123034
2020326391785
202141640666
20222712021
20231922133
2024578650148
202502843172
2026 (to date)11327142

Most common reasons for Boston Scientific Corporation recalls

  • Complaint trend regarding needle shaft gas leaks.37
  • Sterility of device is compromised due to a sterile barrier breach31
  • Potential sterile breach of the pouches in which devices are packaged.12
  • Potential for Capio sutures to break and /or detach.10
  • The needle surface deteriorated due to unexpected electrolysis during procedure.10

What to do if you have a recalled Boston Scientific Corporation product

  1. Match the model, catalog or lot number on your device to the recall.
  2. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
  3. Report problems to FDA MedWatch.

See this week’s new recalls.

All Boston Scientific Corporation recalls

60 shown

Boston Scientific Corporation recall questions

How many recalls has Boston Scientific Corporation had?

573 recalls from Boston Scientific Corporation are on record with U.S. safety agencies, from 2017–2026.

What is the most recent Boston Scientific Corporation recall?

Boston Scientific Corporation recalls NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;, dated Sep 10, 2026. Every Boston Scientific Corporation recall is listed on this page, newest first.

Why are Boston Scientific Corporation products recalled?

The most common reasons on record: Complaint trend regarding needle shaft gas leaks. (37); Sterility of device is compromised due to a sterile barrier breach (31); Potential sterile breach of the pouches in which devices are packaged. (12); Potential for Capio sutures to break and /or detach. (10).

What should I do if I have a recalled Boston Scientific Corporation product?

Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.

How do I get alerts for new Boston Scientific Corporation recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.