Peripheral RotaLink® Plus M0011402500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729838968), received between Nov 12, 2019 and Mar 24, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2022Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS STUCK ON THE WIRE, AND IT CAME OFF AND REMAIN INSIDE THE PATIENT. A 2.50MM ROTALINK PLUS ALONG WITH A PERIPHERAL ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTALINK PLUS BECAME STUCK ON THE ROTAWIRE. WHILE ATTEMPTING TO REMOVE THE DEVICE THE RADIOPAQUE TIP OF THE PERIPHERAL ROTAWIRE CAME OFF AND REMAINED INSIDE THE POPLITEAL ARTERY. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13895809 ↗
• InjuryJul 6, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT BURR BECAME STUCK ON GUIDEWIRE AND IN THE LESION. THE TARGET LESION WAS LOCATED IN LEFT SUPERFICIAL FEMORAL ARTERY. A 2.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE ALONG WITH A ROTAWIRE. DURING PROCEDURE, THE PHYSICIAN NOTED THE BURR BECAME STUCK IN THE FORWARD-THROW POSITION. THE ROTAWIRE AND THE BURR CATHETER COULD NOT BE PULLED BACK AS A SYSTEM. IT WAS THOUGHT THAT THE CATHETER WAS STRETCHED. THE BURR DID NOT 'POP' THROUGH THE LESION AND THE PHYSICIAN BELIEVED THAT THE LESION WAS PREVENTING HIM FROM REMOVING THE SYSTEM OR WIRE. THERE WAS NO KINK IN THE SHEATH OR ANY OTHER ISSUE NOTED. A BALLOON WAS DELIVERED ALONGSIDE WITH THE CATHETER AND PLASTY THE LESION. THE SYSTEM WAS REMOVED AS A UNIT WITHOUT HARM TO THE PATIENT. A NEW 2.25MM BURR WAS INTRODUCED TO TREAT THE LESION AND COMPLETED THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233438 ↗
• MalfunctionJun 17, 2020Output Problem; Intermittent Loss of Power; Output Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE MIDDLE SUPERFICIAL FEMORAL ARTERY (SFA). A 2.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. DURING THE ATHERECTOMY PROCEDURE. IT WAS NOTED THAT THE ROTA BURR KEPT STALLING, THE RPMS DROPPED FROM 170,000 TO 50,000 AND THEN STOPPED. THE DEVICE WAS REMOVED, AND IT WAS REVEALED THAT THERE WAS FIBROUS TISSUE ON THE GUIDEWIRE. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10164820 ↗
• MalfunctionNov 12, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 2.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING WITHDRAWAL, IT WAS NOTED THAT THE CATHETER BROKE IN HALF AS IT WAS SEPARATED IN THE MID-SECTION. THE CATHETER WAS THEN COMPLETELY REMOVED FROM THE PATIENT'S BODY BY NORMAL PIN PULLED OUT METHOD INCLUDING THE WIRE. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND HAD A GOOD RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311549 ↗