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Carrier™ Delivery Catheter CR7074Recalls & reported problems

Balt USA LLC · The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier™ Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier™ Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier™ Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
1
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810068561982), received between Aug 21, 2024 and Feb 27, 2026 — classified as 1 death, 1 injury.

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Perforation of Vessels1
  • Vascular Dissection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • DeathFeb 27, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT: "TEXT RECEIVED FROM THE PHYSICIAN "HAD VESSEL RUPTURE WITH RAPTOR/CARRIER LAST NIGHT. I DON'T THINK IT WAS DEVICE RELATED. PULLED OUT A LONG FIRM CLOT ON 6TH PASS AND HAD EXTRAV FROM M1 PROBABLY AVULSED M2 PT DIED"" UPDATE 28JAN2026 - ADDITIONAL INFORMATION RECEIVED FROM THE ISSUER: "PASSING ALONG THIS COMPLAINT. I DO NOT YET HAVE SPECIFIC REFERENCE NUMBERS OR LOTS; WILL FORWARD WHEN THEY BECOME AVAILABLE. WANTED TO DOCUMENT BECAUSE PATIENT DEATH WAS REPORTED. PHYSICIAN DOES NOT BELIEVE THIS WAS A DEVICE RELATED INJURY."

    Patient problems: Perforation of Vessels

    MAUDE report 24475681 ↗
  • InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT: "PHYSICIAN DISSECTED M1. M1 TAKEOFF WAS TORTUOUS AND THE CASE WAS CHALLENGING. ORIGINALLY REPORTED (B)(6) 2024 IN LMR FORM AND MANAGEMENT REPORT IN IPHONE NOTES. THE PHYSICIAN DID NOT USE A GUIDEWIRE WITH CARRIER. HE CONFIRMED THAT HE IS NOT SURE IT WAS THE CARRIER THAT DISSECTED THE M1, AS MANY OTHER SYSTEMS WERE USED IN THE CASE INCLUDING A SEPARATE GUIDEWIRE & MICROCATHETER SYSTEM AND A STENT RETRIEVER. PHYSICIAN MENTIONED HE WOULD CONSIDER USING A WIRE NEXT TIME WITH DIFFICULT ANATOMY." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

    Patient problems: Vascular Dissection

    MAUDE report 20009473 ↗

Other Catheter, Percutaneous devices

All Catheter, Percutaneous devices →

Sources and updates

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