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.
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: 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
- Affected units
- 1,058
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.
Part of a larger recall action
This product is one of 14 recalled by Cordis US Corp 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.
See all 14 products in this recall →Related recalls
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