Boston Scientific Recalls Expel Drainage Catheters Due to Fragmentation Risk
Boston Scientific is recalling Expel APD and APDL Drainage Catheters after one report of device fragmentation in the biliary system.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves device fragmentation requiring additional intervention, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is initiating a Medical Device Field Correction for specific models of Expel Drainage Catheters, including the APD and APDL series. The recall involves 918 units distributed worldwide, including in the United States and several European countries.
The recall was initiated after Boston Scientific received one complaint regarding device fragmentation following the implantation of an Expel APD catheter in the biliary system. The most serious foreseeable patient risk associated with this issue is the need for additional intervention to retrieve the fragments using minimally invasive methods.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and product codes listed in the official recall notice. If the affected devices are in use, providers should contact Boston Scientific for instructions on replacement or retrieval.
The recalled product
- Product
- Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 918
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)
- 17362835
- 17501623
- 17617274. H7493931008200- 17259557
- 17297984
- 17362834
- 17376747. H7493931010200- 17318044
- 17376748
- 17459140
- 17501573
- 17617545. H7493931012250- 17275816
- 17501620
- 17575123
- 17617353. H7493931014250- 17370708
- 17604432
- 17624928. H7493931106150- 17259581
- 17365684
- 17617551. H7493931108150- 17244079
- 17404400
- 17408751
- 17493552
Distribution
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