ANGIOGUARD Emboli Capture Guidewire System Recalled Due to Device Separation
The FDA has recalled the ANGIOGUARD RX/XP Emboli Capture Guidewire System because the delivery system and capture sheath could separate during use, potentially causing stroke or requiring emergency surgery.
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: FDA Class I classification applies. The device separation poses significant risk of stroke and may require emergency surgical intervention during procedures.
Plain-English summary
The FDA has issued a Class I recall of the ANGIOGUARD RX / XP Emboli Capture Guidewire System (REF 601814RE), manufactured by Cordis US Corp. The device is a guidewire system used in vascular procedures to capture emboli.
There is a potential for separation between the delivery system and the capture sheath during the medical procedure. This separation could lead to stroke, intra-procedural delays, or the need for unplanned percutaneous or surgical intervention while a replacement device is prepared.
1058 units of this device have been distributed worldwide across multiple lot numbers. Healthcare providers and facilities using this device should immediately discontinue use and contact Cordis US Corp for instructions on the return or replacement of affected units. Patients who have received this device should consult their healthcare provider.
The recalled product
- Product
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
- Manufacturer
- Cordis US Corp
- Hazard
- device-separation
- stroke-risk
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 (14)
- UDI/DI 20705032056714
- Lot Numbers: 35264218
- 35264224
- 35264806
- 35265342
- 35265343
- 35265382
- 35265383
- 35265646
- 35265656
- 35265658
- 35264206
- 35265645
- 35265653
Distribution
Distribution scope not specified by the agency.
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