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Sprinter™ SPR2512WRecalls & reported problems

Medtronic, Inc. · BALLOON SPR2512W SPRINTER OTW 2.5X12MM · Class 2

All models of Sprinter (6)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169850491), received between Jun 8, 2022 and Jun 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Jun 24, 2022Open, Classified

    Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

    Z-1483-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Device Markings/Labelling Problem1

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.

  • MalfunctionJun 8, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

    AN ATTEMPT WAS MADE TO USE A SPRINTER OTW PTCA BALLOON CATHETER IN A SEVERELY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND THE RIGHT COMMON FEMORAL ARTERY (SFA/CFA) WITH 100% STENOSIS FOR SFA AND 85% STENOSIS FOR CFA. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE SPRINTER OTW DEVICE WAS BACK LOADED WITH A 0.014¿ WIRE WITHOUT ANY ISSUES. WHEN THE WIRE WAS EXCHANGED, IT CAME OUT OK HOWEVER THE NEXT WIRE USED WOULD NOT ADVANCE. THE BALLOON CATHETER HAD TO BE CUT TO REMOVE THE GUIDEWIRE. AFTER THE PROCEDURE THE PRODUCT WAS REVIEWED TO DETERMINE WHY THE WIRE WOULD NOT PASS THROUGH AND FOUND THAT THE BALLOON WAS A 2.25 X12MM, THE PACKAGING DETAILED A 2.5 X X12MM DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14632446 ↗

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Sources and updates

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