Symmetry Surgical e2400-52Recalls & reported problems
Aspen Surgical Products, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841785113413), received between Jul 17, 2025 and Jul 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Defective Component; Defective Component
COMPLIANT ALLEGES, "IT (CATH 1) WAS DIRTY FROM ATTEMPTED USE AND THE BALLOON DID NOT INFLATE. THE OTHER ONE (CATH 2) POPPED WHILE IN USE AND NOT FROM OVER-INFLATION. IT MAY HAVE HAD A DEFECT IN THE BALLOON AS WELL. BOTH ARE FROM BATCH #442310 BOTH CATHETERS ARE DEFECTIVE. ONLY 1 UNIQUE PATIENT WAS INVOLVED. THE PATIENT WAS NOT HARMED AS A RESULT. THE PROCEDURE WAS NOT DELAYED. THE DEVICES WERE INSPECTED BEFORE USE BUT THE INSPECTION IS NOT DOCUMENTED. CATH 1: A BALLOON INFLATION TEST WAS NOT PERFORMED PRIOR TO USE AS THIS CHANGES THE SIZE OF THE BALLOON AND IT DOES NOT FIT DOWN THE LUMEN OF THE CATHETER AND IS MORE LIKELY TO GET TORN INTRA-OP ONCE TESTED. CATH 2: THE BALLOON RUPTURED DURING INFLATION. IT WAS FILLED TO THE AMOUNT INDICATED ON THE SYRINGE. IT POPPED BEFORE REMOVAL. STERILE SALINE WAS USED TO INFLATE IT. THERE WERE NO VISIBLE SIGNS OF A DEFECT PRIOR TO USE. ONCE IT POPPED IT DID NOT INFLATE AGAIN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531647 ↗
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- Fanelli G12950Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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