Home › APPLIED MEDICAL RESOURCES CORPORATION › Syntel Embolectomy Catheter (Spring Tip)
Syntel Embolectomy Catheter (Spring Tip)
APPLIED MEDICAL RESOURCES CORPORATION · Model A4F03 · UDI-DI 00607915111069
DXE
Prescription
10
510(k) clearances
7,736
Adverse events (143 deaths)
57
Recalls
41
Facilities
Description
Embolectomy/thrombectomy balloon catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | PFM MEDICAL INC. | A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro- |
| 2025-04-11 | LeMaitre Vascular, Inc. | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| 2024-04-17 | LeMaitre Vascular, Inc. | The guide tip can become damaged and result in the tip detaching. |
| 2023-09-07 | Edwards Lifesciences, LLC | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). |
| 2022-10-06 | Edwards Lifesciences, LLC | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
| 2022-10-06 | Edwards Lifesciences, LLC | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
| 2022-09-30 | LeMaitre Vascular, Inc. | Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the ca |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.