Expo 5F Selective Angiographic Catheters Recalled for Inner Lining Material Failure
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter's inner lining. This prevents guidewire advancement through the catheter.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a cardiac catheter with confirmed polyurethane delamination and material detachment. FDA Class I recalls must be scored at minimum 4 (Severe), and no deaths or serious injuries are reported in the source.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F Expo Kimny, 5-pack) due to a structural defect in the catheter's construction.
The polyurethane layer in certain batches has delaminated, with material detaching from the catheter's inner lining. This prevents the guidewire from advancing properly through the catheter lumen, which could impact the success of the angiographic procedure.
This recall affects 230 catheters with batch numbers 60504831, 60515598, and 60533629 (UDI/DI 08714729249030). The devices were distributed worldwide, including the United States, US territories, Canada, EMEA, LATAM, and Asia Pacific regions.
Patients and healthcare providers should immediately stop using affected units and contact Boston Scientific for replacement instructions. Healthcare facilities should quarantine and remove these catheters from service.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-delamination
- material-detachment
- device-malfunction
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 (4)
- UDI/DI 08714729249030
- Batch Numbers: 60504831
- 60515598
- 60533629
Distribution
Distribution scope not specified by the agency.
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