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.
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: 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
- Affected units
- 230
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.
Part of a larger recall action
This product is one of 48 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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See all →- SevereExpo 5F cardiac catheters recalled for material delamination worldwide
FDA (Devices) · 2024-05-22
- SevereExpo 5F Catheters Recalled for Guidewire Advancement Failure
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- SevereExpo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
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FDA (Devices) · 2024-05-22
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