MAXI 4161860LRecalls & reported problems
Cordis US Corp. · MAXI LD PTA F7 110 18X6 · Class 2
Data updated Oct 13, 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 20705032002254), received between Dec 21, 2021 and Dec 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Deflation Problem1
- Detachment of Device or Device Component1
- Difficult to Remove1
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.
MalfunctionDec 21, 2021Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component
AS REPORTED, A MAXI LD 7F 18X6 110CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS USED AND INFLATED NORMALLY, BUT THERE WAS A LOT OF RESISTANCE WHEN WITHDRAWING THE BALLOON AFTER DEFLATION. IT WAS IMPOSSIBLE TO WITHDRAW THE BALLOON NORMALLY. AFTER FINALLY WITHDRAWING THE BALLOON, IT WAS FOUND THAT IT DID NOT FOLD NORMALLY DURING DEFLATION. THE BALLOON WAS REMOVED BY USING THE GUIDE TO PULL IT OUT WITH FORCE. THE PROCEDURE WAS THEN COMPLETED WITH "NORMAL PROCESS". THERE WAS NO PATIENT INJURY. THE DEVICE WAS BEING USED FOR TREATMENT OF A HEPATIC VEIN DUE TO BUDD CHIARI SYNDROME. THE BALLOON DIAMETER AFTER DEFLATION WAS TOO LARGE AND IT COULD NOT BE WITHDRAWN. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. A "NORMAL" RATIO OF CONTRAST AND SALINE WAS USED. THE SAME INDEFLATOR WAS NOT USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON WAS INFLATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13050989 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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