Syntel Thrombectomy Catheter A4545Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915110925), received between May 6, 2016 and Nov 29, 2017 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2017Material Separation; Material Separation

  INCIDENT DESCRIPTION: "THE TIP BROKE OFF. " ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM RN, (B)(6) ON FRIDAY (B)(6) 2017 AT 6:21 AM: "THROMBECTOMY CATHETER INSERTED THROUGH MERIT 8F SHEATH (PSS-8F-4MT) INTO THE BRACHIAL ARTERY. INFLATED AND PULLED BACK TO TIP OF SHEATH, DEFLATED AND REMOVED. THIS WAS DOWN SUCCESSFULLY TWICE. ON THE THIRD TIME, THE TIP OF THE CATHETER CAME OFF INSIDE THE PATIENT'S GRAFT. NEW CATHETER (A4F04) WAS USED TO TRY TO RETRIEVE THE TIP, BUT WAS UNSUCCESSFUL. AT THIS TIME, THERE IS NO ILL EFFECT TO THE PATIENT. THE FAULTY PRODUCT WAS NOT SAVED TO BE RETURNED. TYPE OF INTERVENTION: NONE. PATIENT STATUS: "THERE IS NO ILL EFFECT TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068026 ↗
• MalfunctionOct 24, 2017Break; Break

  PROCEDURE PERFORMED: "THROMBECTOMY OF DIALYSIS GRAFT" INCIDENT DESCRIPTION: THIS CER IS IN CORRELATION WITH (B)(4). "JUST HAD ANOTHER TIP BREAK OFF, BUT NOT ABLE TO RETRIEVE, STILL IN PATIENT." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM REGISTERED NURSE, (B)(6) ON MONDAY, (B)(6) 2017 AT 9:40 AM. "AFTER INSERTING THE FOGARTY THROUGH THE SHEATH, IT WAS INFLATED AND PULLED BACK PER NORMAL USE. ON EACH OF THE THREE OCCASIONS, THE TIP OF THE FOGARTY CAME OFF INSIDE THE GRAFT. IN THE FIRST PROCEDURE ((B)(6) 2017), THE TIPS WERE ABLE TO BE RECOVERED USING ANOTHER FOGARTY WHILE APPLYING SUCTION ON THE PIGTAIL OF THE SHEATH. THE SECOND PROCEDURE ((B)(6) 2017) THE TIP WAS UNABLE TO BE RECOVERED. FIRST PATIENT NO ILL EFFECTS D/T THE FACT THAT THE TIPS WERE RECOVERED BEFORE FLOW WAS RE-ESTABLISHED. THE SECOND PATIENT HAD NO ILL EFFECT EVEN THOUGH THE TIP COULD NOT BE RECOVERED." ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE FROM REGISTERED NURSE, (B)(6) ON MONDAY, 16-OCT-2017 AT 10:38 AM "I WILL HAVE TO CHECK ON THE INCIDENT DATE THAT OCCURRED ON THE FIRST TWO INCIDENTS. I PUT THE WRONG PRODUCT CODE IN MY EMAIL, IT SHOULD BE THE A4545 CATHETER. THERE IS NO POSSIBLE WAY FOR US TO RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6973866 ↗
• MalfunctionOct 9, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: THROMBECTOMY OF FOREARM AV GRAFT DIALYSIS INCIDENT DESCRIPTION: CER 1 OF 2: (B)(4), CER 2 OF 2: (B)(4). INSERTED A FRENCH MERIT SHEATH INTO THE GRAFT. INFLATED THE CATHETER AND PULLED BACK TO REMOVE THE CLOT. DR NOTICED THE BALLOON OF THE CATHETER WAS DEFLATED AND THAT THE TIP OF THE CATHETER HAD BROKEN INSIDE THE GRAFT. TRIED TO COMPLETE WITH 2ND A4545 OF THE SAME LOT NUMBER AND THE SAME THING HAPPENED. USED ANOTHER A4545 AND THE THIRD CATHETER WORKED. THE SAME LOT NUMBER FOR ALL THREE CATHETERS. RETRIEVED BOTH TIPS, BUT ONLY ONE IS AVAILABLE TO RETURN AS THE DOCTOR DISCARDED 1 OF THE TIPS. TYPE OF INTERVENTION: USED THIRD A4545 TO COMPLETE THE PROCEDURE PATIENT STATUS: "NO ILL EFFECT."

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6930148 ↗
• MalfunctionOct 9, 2017Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: THROMBECTOMY OF FOREARM AV GRAFT DIALYSIS. INCIDENT DESCRIPTION: CER 1 OF 2: (B)(4), CER 2 OF 2: (B)(4). INSERTED A FRENCH MERIT SHEATH INTO THE GRAFT. INFLATED THE CATHETER AND PULLED BACK TO REMOVE THE CLOT. DR NOTICED THE BALLOON OF THE CATHETER WAS DEFLATED AND THAT THE TIP OF THE CATHETER HAD BROKEN INSIDE THE GRAFT. TRIED TO COMPLETE WITH 2ND A4545 OF THE SAME LOT NUMBER AND THE SAME THING HAPPENED. USED ANOTHER A4545 AND THE THIRD CATHETER WORKED. THE SAME LOT NUMBER FOR ALL THREE CATHETERS. RETRIEVED BOTH TIPS, BUT ONLY ONE IS AVAILABLE TO RETURN AS THE DOCTOR DISCARDED 1 OF THE TIPS. TYPE OF INTERVENTION: USED THIRD A4545 TO COMPLETE THE PROCEDURE. PATIENT STATUS: "NO ILL EFFECT."

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6930134 ↗
• MalfunctionJun 27, 2017Material Rupture; Material Rupture

  PROCEDURE PERFORMED: THROMBECTOMY. INCIDENT DESCRIPTION: AFTER DR. GRANT WENT TO INSUFFLATE BALLOON, HE PASSED IT THROUGH THE VESSEL AND AFTER PULLING BALLOON OUT, HE NOTICED THE BALLOON WAS RUPTURED. IT WAS NOTED THERE WAS SOME KIND OF SMALL FIBER ATTACHED TO THE BALLOON. THIS HAPPENED IN THE BEGINNING OF THE CASE. THE CATHETER DID NOT COME INTO CONTACT WITH ANY SHARP OBJECTS THROUGHOUT THE CASE. PATIENT STATUS: THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6672064 ↗
• MalfunctionMay 6, 2016Detachment Of Device Component; Detachment Of Device Component

  THROMBECTOMY - "WHILE USING THE CATHETER FOR A THROMBECTOMY, PHYSICIAN INJECTED BALLOON 0.7 ML OF CONTRAST. AFTER DEFLATING THE BALLOON AND REMOVING THE CATHETER THE DOCTOR NOTICED THAT THE TIP OF THE CATHETER WAS MISSING. THE CLEAR PLASTIC TIP OVER THE COIL SPRING WAS GONE. STAFF NOTICED AN OBJECT IN THE PATIENT'S WRIST FOR A SHORT TIME BUT DISAPPEARED AFTER THE CONTRAST DISPERSED. THE STAFF WAS THEN UNABLE TO FIND THE CATHETER TIP UNDER FLURO DUE TO THE OBJECT NOT BEING RADIO OPAQUE." PATIENT STATUS - THE PATIENT REMAINED ASYMPTOMATIC THROUGHOUT THE CASE AS WELL AS AFTERWARDS.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 5639151 ↗