VSI IPN029498Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841156103019), received between Oct 26, 2020 and May 11, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Material Separation

  IT WAS REPORTED THAT "THE MICRO-INTRODUCER KIT BROKE WHILE OUR INTERVENTIONAL RADIOLOGIST WAS PLACING THE CATHETER IN THE PATIENT'S RIGHT COMMON FEMORAL ARTERY OVER A GUIDEWIRE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE OF EQUIPMENT." GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND TO ASSESS WHETHER ANY PATIENT HARM, INJURY, OR ADVERSE HEALTH CONSEQUENCES OCCURRED. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 25142942 ↗
• InjuryJan 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "ISSUE WITH THE TRANSITION DILATOR FROM ONE OF TELEFLEX'S MICRO PUNCTURE KITS. DURING THE PROCEDURE, THE OUTER CATHETER OF THE TRANSITION DILATOR DISCONNECTED FROM THE HUB AND BECAME A FOREIGN BODY INSIDE THE PATIENT." ADDITIONAL INFORMATION: PROCEDURE WAS PLACEMENT OF A NON-TUNNELED CENTRAL LINE; ACCESS SITE WAS RIJ. THE PATIENT DID HAVE TO HAVE AN ADDITIONAL PROCEDURE FOR RETRIEVAL, WHICH HAPPENED IMMEDIATELY ON THE TABLE AND CONSISTED OF AN ADDITIONAL ACCESS SITE AT THE RIGHT FEMORAL VEIN. THE DEVICE WAS SUCCESSFULLY REMOVED. THE PATIENT DID WELL AFTER THE PROCEDURE WITHOUT ANY COMPLICATIONS. NO INJURIES OCCURRED FROM THIS INCIDENT. THE PATIENT DID NOT EXPERIENCE AND SIGNS/SYMPTOMS DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18563000 ↗
• InjuryOct 26, 2020Break; Break

  PER MEDWATCH RECEIVED 29SEP2020 MEDWATCH (B)(4). PER MEDWATCH FORM: PER SURGEON'S OP NOTE: THE 21 GAUGE NEEDLE OF THE MICROCATHETER INTRODUCER KIT WAS USED TO CANNULIZE THE LEFT SUBCLAVIAN VEIN, WHICH WAS DONE EASILY. WE HAD GOOD BLOOD RETURN. THE FINE WIRE OF THE MICROCATHETER INTRODUCER KIT WAS THEN THREADED THROUGH THE 21 GAUGE NEEDLE. THE WIRE WOULD NOT PASS. THE NEEDLE WAS WITHDRAWN. UPON ATTEMPTING TO REMOVE THE WIRE, IT SEEMED TO BE STUCK IN THE CLAVIPECTORAL FASCIA. WE EMPLOYED FLUOROSCOPY AND INDEED IT APPEARED THAT THE VERY FLEXIBLE TIP OF THIS FINE J-WIRE HAD ACTUALLY DOUBLED BACK AND EVEN KNOTTED ON ITSELF. IT COULD NOT BE RETRIEVED MANUALLY. FOR THIS REASON, AFTER INFILTRATING ADDITIONAL LOCAL ANESTHESIA, I EXTENDED THE PORT POCKET INCISION IN THE LEFT INFRACLAVICULAR SPACE. A COMBINATION OF SHARP AND BLUNT DISSECTION WAS USED TO DISSECT DOWN TO THE CLAVICLE AT THE ENTRY SITE OF THE WIRE. USING FLUOROSCOPY, WE DETERMINED THE EXACT LOCATION OF THIS COILED AND KNOTTED TIP OF THE WIRE AND IT WAS REMOVED WITH BLUNT AND SHARP DISSECTION FROM THE CLAVIPECTORAL FASCIA. IT WAS ACTUALLY REMOVED IN 2 SMALL PIECES AT THE TIP. WE EMPLOYED FLUOROSCOPY TO IDENTIFY THE LOCATION AND T

  Patient problems: Foreign Body Embolism

  MAUDE report 10736614 ↗