Boston Scientific steerable sheath devices recalled due to manufacturing defect risk
Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Although no illnesses or injuries have been reported, the manufacturing defect poses significant risk of patient harm during clinical use, justifying the Severe rating per the rubric's requirement that Class I recalls score no lower than 4.
Plain-English summary
Boston Scientific Corporation is recalling 461 POLARSHEATH Steerable Sheath 12F devices (Model M004CRBS3050) due to a manufacturing defect identified in specific production batches.
A tooling error during manufacturing may have caused delamination of the inner lumen of the sheath shaft in a subset of devices. This defect could result in embolization—the breaking loose and migration of a device fragment—during clinical use, such as when flushing the sheath or introducing a dilator or ablation catheter.
The affected devices were distributed internationally to Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan. Affected batch numbers are documented by Boston Scientific (GTIN 08714729992684).
Healthcare facilities should verify whether they have received any of the recalled devices and contact Boston Scientific for instructions on device replacement or proper disposal.
The recalled product
- Product
- Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 461
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 08714729992684
- Batch Numbers: 32895945
- 32895947
- 32903274
- 32903275
- 32903276
- 32903277
- 32903278
- 32903340
- 32999267
- 33000331
- 33000333
- 33000334
- 33000337
- 33000338
- 33000339
- 33052646
- 33052647
- 33052648
- 33052649
Distribution
Distribution scope not specified by the agency.
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