Boston Scientific Recalls Biliary Drainage Catheters Due to Fragmentation Risk
Boston Scientific is recalling specific lots of Expel Drainage Catheters because they may fragment after implantation, potentially requiring additional medical procedures to remove the pieces.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II and involves a structural defect (fragmentation) that has resulted in reported cases of additional invasive medical interventions, meeting the criteria for a Severe rating.
Plain-English summary
Boston Scientific Corporation is recalling 289 units of various lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits. The recall is due to complaints that the devices fragmented after being implanted in the biliary system.
The most serious patient risk associated with this issue is the need for additional intervention to retrieve the fragments using minimally invasive methods. In some reported cases, these procedures were performed to remove the device fragments.
The affected products were distributed worldwide, including in the United States (California, Wisconsin, Florida, and Ohio) and in several European countries. The specific lots involved have expiration dates between January 30, 2016, and May 8, 2016. Healthcare providers and patients should check their device lot numbers against the list provided by the manufacturer and contact Boston Scientific for further instructions.
The recalled product
- Product
- Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 289
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 (19)
- UPN # LOT # H7493933108200 17245003
- 17416605
- 17489192 H7493933108350 17245004
- 17245005
- 17370709
- 17408756 H749393310835K1 17411333
- 17493554 H7493933110200 17318047 H7493933110350 17275822
- 17438003
- 17494025
- 17501572 H749393311035K1 17328808
- 17403871
- 17416578
- 17459144 H7493933110400 17275824
- 17416608 H7493933112350 17245006
- 17259580
- 17275819 H7493933114350 17275815
- 17338207 with Expiration Dates between January 30
- 2016 and May 8
- 2016
Distribution
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