RotaWire™ Drive and wireClip™ Torquer H74939463001Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729996231), received between May 20, 2025 and Sep 11, 2026 — classified as 7 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (9 reports).

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

3 other recalls cover devices cleared under the same FDA submission (P900056); they may or may not involve this specific model.

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.

Recalls naming this device

1. Mar 8, 2022Class IIOpen, Classified

   Pouch seals may be open, compromising sterility.

   Z-0916-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Detachment of Device or Device Component

  It was reported that the wire detached and a perforation occurred requiring additional surgery.The 15mm long and 95% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery with a vessel diameter of 3.0 mm. A 1.25mm Rotapro and Rotawire Drive were selected for use. During the procedure, difficulty crossing the lesion was experienced. Seventeen ablations were performed at a set speed of 190,000 rpm for 15 seconds each. The physician noted reductions in speed ranging from 2,000 to 10,000 rpm during ablation. A perforation was observed on the opposite side of the calcified nodule and upon withdrawal of the devices it was noted that the RotaWire had separated a few centimeters proximal to the radiopaque marker. It was considered possible that the separation was due to burr contact. Bypass grafting of the proximal LAD was performed to treat the perforation. No device fragments were left inside the body. Following surgery, the patient was weaned from mechanical ventilation, resumed oral intake, and is currently undergoing rehabilitation.

  Patient problems: Perforation

  MAUDE report 50735310 ↗
• MalfunctionAug 19, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50333759 ↗
• MalfunctionAug 18, 2026Entrapment of Device

  It was reported that a burr stuck on guidewire issue occurred.A 1.50mm ROTAPRO was selected for treatment of the target lesion that was located in the right coronary artery (RCA) and was moderately calcified and mildly tortuous. During the procedure, while adjusting the rotation speed, it was noted that the drill head broke off outside of the patient. A new 1.50mm ROTAPRO was selected for treatment to continue the procedure. After several runs, it was noted that the burr could no longer move over the wire. It was attempted to move the knob several times; however, the issue did not resolve. The ROTAPRO and wire were completely removed together, and the procedure was completed as planned with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308202 ↗
• MalfunctionJul 30, 2026Fracture; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085703 ↗
• MalfunctionJul 9, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT THE ROTA BURR GOT STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING THE PROCEDURE, INSIDE THE PATIENT, THE BURR GOT STUCK WITH THE ROTAWIRE. THE DEVICES WERE REMOVED AS ONE UNIT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25774274 ↗
• InjuryJun 4, 2026Difficult to Remove; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE SEPARATION OCCURRED WITH A RETAINED FRAGMENT AND PROCEDURE WAS CANCELLED. THE 30 MM LONG AND 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY WITH A VESSEL DIAMETER OF 3.00- 3.40 MM. A ROTAWIRE AND 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING REMOVAL, RESISTANCE WAS ENCOUNTERED AND AN UNUSUAL SOUND WAS HEARD. THE GUIDEWIRE DETACHED 5 CM FROM THE TIP DUE TO CONTACT WITH THE BURR. PER THE PHYSICIAN. THE WIRE MAY HAVE BEEN KINKED. ATTEMPTS TO RETRIEVE THE DEVICE FRAGMENT WITH A NON-BOSTON SCIENTIFIC BALLOONS, GUIDE EXTENSION CATHETER AND GUIDEWIRE WERE UNSUCCESSFUL. THE DETACHED DEVICE SEGMENT REMAINED INSIDE THE PATIENT AND THE PROCEDURE WAS CANCELLED AS THERE WERE NO ADDITIONAL DEVICES AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25398411 ↗
• MalfunctionMay 27, 2026Nonstandard Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A WIRE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A ROTAWIRE DRIVE WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT A PART OF THE WIRE BROKE OFF IN THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303151 ↗
• MalfunctionMay 20, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT THE ROTABURR WAS STUCK WITH THE ROTAWIRE. A 2.00MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. UPON REMOVAL FROM THE BODY AFTER ABLATION, THE ROTAPRO BECAME STUCK WITH THE ROTAWIRE. THE DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232041 ↗
• MalfunctionApr 27, 2026Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE GUIDEWIRE, AND A REMOVAL DIFFICULTY OCCURRED. A 1.50 MM ROTAPRO BURR AND ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING WITHDRAWAL, WHEN ATTEMPTING TO REMOVE THE DEVICE AFTER ABLATION, THE WIRE AND BURR BECAME TRAPPED AND COULD NOT BE MOVED. AS A RESULT, BOTH THE WIRE AND THE BURR WERE REPLACED. THE DEVICES WERE REMOVED NORMALLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002432 ↗
• InjuryApr 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED VIA VOLUNTARY MEDWATCH REPORT #(B)(4) THAT A DEVICE DETACHMENT OCCURRED, RESULTING IN VESSEL PERFORATION AND AN UNRETRIEVED DEVICE FRAGMENT THAT REQUIRED ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CORONARY HEART DISEASE, AND HYPERTENSION, AND UNDERWENT LEFT AND RIGHT HEART CATHETERIZATION WITH CORONARY ANGIOGRAPHY AND IMPELLA SUPPORT. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A ROTAWIRE DRIVE AND ROTAPRO WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAWIRE EXTRA SUPPORT BROKE DURING A ROTATIONAL ATHERECTOMY RUN, RESULTING IN VESSEL PERFORATION AND A RETAINED WIRE FRAGMENT. A COVERED STENT WAS PLACED TO STABILIZE THE PERFORATION, FOLLOWED BY TWO ADDITIONAL STENTS TO SECURE THE RETAINED WIRE IN PLACE AND OPEN VESSEL. THE PHYSICIAN THEN REQUESTED INTUBATION, A CODE WAS CALLED, AND A PERICARDIAL DRAIN WAS PLACED WITH REINFUSION OF BLOOD VIA SHEATH. WHILE THIS WAS A COMPLEX CARDIAC CATHETERIZATION CASE WITH AN INHERENTLY INCREASED RISK OF COMPLICATIONS, THE PHYSICIAN OPTED TO RETAIN THE WIRE FRAGMENT IN PLACE DUE TO THE PATIENT'S CRITICAL CONDITION. A SUBSEQUENT ECHOCARDIOGRAM REVEALED TH

  Patient problems: Foreign Body In Patient; Perforation of Vessels; Pericardial Effusion

  MAUDE report 24805272 ↗
• InjuryJan 15, 2026Difficult to Remove

  IT WAS REPORTED THAT DEVICE WAS DIFFICULT TO REMOVE. THE 90% STENOSED, 15 X 3.00MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A ROTAWIRE DRIVE WAS SELECTED FOR USE WITH A ROTAPRO AND ABLATION WAS PERFORMED WITHOUT ANY ISSUES. THE ROTAWIRE BECAME STUCK IN THE PERIPHERAL LAD SO A MICROCATHETER WAS ADVANCED, AND AN ATTEMPT WAS MADE TO REPLACE THE WIRE WITH AN 0.014 WIRE. DUE TO STRONG RESISTANCE AND CONCERNS ABOUT WIRE SEPARATION, ACTIONS WERE STOPPED. THE ADVANCEMENT OF THE MICROCATHETER WAS ALSO INSUFFICIENT, SO TO SOFTEN THE CALCIFICATION, INTRAVASCULAR LITHOTRIPSY (IVL) WAS PERFORMED ON THE PROXIMAL LAD. AFTERWARD, THE CATHETER WAS ABLE TO CROSS MORE EASILY AND THE ROTAWIRE WAS SUCCESSFULLY RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086253 ↗
• MalfunctionNov 25, 2025Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE ROTA BURR GOT STUCK WITH THE ROTAWIRE. A ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAPRO AND ROTAWIRE BECAME STUCK TOGETHER AND WERE REMOVED SIMULTANEOUSLY. THE REMOVAL DIFFICULTY OCCURRED DUE TO A KINK OBSERVED IN THE ROTAWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648759 ↗
• InjuryNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE DEVICE DETACHED AND REMAINED IN THE PATIENT. A ROTAWIRE DRIVE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE AND REMAINED IN THE PATIENT'S ARTERY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23575054 ↗
• InjuryNov 17, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A ROTAWIRE DRIVE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE IMPERMEABLE OPAQUE SECTION OF THE DEVICE KINKED WITHIN THE CORONARY ARTERY, CAUSING OPERATIONAL DIFFICULTIES. RESISTANCE WAS FELT UPON REMOVAL, AND A MICROCATHETER WAS USED TO REMOVE THE DEVICE AND AVOID FRACTURING OF THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572141 ↗
• MalfunctionNov 17, 2025Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. FIVE ROTAWIRE DRIVE WIRES WERE SELECTED FOR ROTABLATION. DURING INSERTION, EXCESSIVE COATING WAS OBSERVED ON THE WIRES, CAUSING THE ROTAWIRE ADHERE TO THE BURR. IN DYNAGLIDE MODE, THE WIRE WAS UNABLE TO ADVANCE NORMALLY. IT WAS LATER NOTED THAT THE FIRST WIRE HAD ACCUMULATED MULTIPLE FIBERS FROM THE DRAPE, FORMING A BALL OF FLUFF THAT ADVANCED TOWARD THE CORONARY ARTERY. ATTEMPTS TO USE THE REMAINING FOUR WIRES YIELDED SIMILAR RESULTS. THE FINAL WIRE SEIZED WITHIN THE BURR, APPEARING TO HAVE FIBERS ADHERED TO IT AS IF BY GLUE. DESPITE MULTIPLE ATTEMPTS TO CLEAN THE WIRE, INCLUDING WIPING IT END-TO-END APPROXIMATELY TEN TIMES AND MANUALLY REMOVING THE LUMPS, THE WIRE REMAINED STICKY AND UNUSABLE. THE PROCEDURE WAS PROLONGED BUT ULTIMATELY COMPLETED WITH A ANOTHER ROTAWIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568167 ↗
• MalfunctionNov 17, 2025Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. FIVE ROTAWIRE DRIVE WIRES WERE SELECTED FOR ROTABLATION. DURING INSERTION, EXCESSIVE COATING WAS OBSERVED ON THE WIRES, CAUSING THE ROTAWIRE ADHERE TO THE BURR. IN DYNAGLIDE MODE, THE WIRE WAS UNABLE TO ADVANCE NORMALLY. IT WAS LATER NOTED THAT THE FIRST WIRE HAD ACCUMULATED MULTIPLE FIBERS FROM THE DRAPE, FORMING A BALL OF FLUFF THAT ADVANCED TOWARD THE CORONARY ARTERY. ATTEMPTS TO USE THE REMAINING FOUR WIRES YIELDED SIMILAR RESULTS. THE FINAL WIRE SEIZED WITHIN THE BURR, APPEARING TO HAVE FIBERS ADHERED TO IT AS IF BY GLUE. DESPITE MULTIPLE ATTEMPTS TO CLEAN THE WIRE, INCLUDING WIPING IT END-TO-END APPROXIMATELY TEN TIMES AND MANUALLY REMOVING THE LUMPS, THE WIRE REMAINED STICKY AND UNUSABLE. THE PROCEDURE WAS PROLONGED BUT ULTIMATELY COMPLETED WITH A ANOTHER ROTAWIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568166 ↗
• MalfunctionNov 17, 2025Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. FIVE ROTAWIRE DRIVE WIRES WERE SELECTED FOR ROTABLATION. DURING INSERTION, EXCESSIVE COATING WAS OBSERVED ON THE WIRES, CAUSING THE ROTAWIRE ADHERE TO THE BURR. IN DYNAGLIDE MODE, THE WIRE WAS UNABLE TO ADVANCE NORMALLY. IT WAS LATER NOTED THAT THE FIRST WIRE HAD ACCUMULATED MULTIPLE FIBERS FROM THE DRAPE, FORMING A BALL OF FLUFF THAT ADVANCED TOWARD THE CORONARY ARTERY. ATTEMPTS TO USE THE REMAINING FOUR WIRES YIELDED SIMILAR RESULTS. THE FINAL WIRE SEIZED WITHIN THE BURR, APPEARING TO HAVE FIBERS ADHERED TO IT AS IF BY GLUE. DESPITE MULTIPLE ATTEMPTS TO CLEAN THE WIRE, INCLUDING WIPING IT END-TO-END APPROXIMATELY TEN TIMES AND MANUALLY REMOVING THE LUMPS, THE WIRE REMAINED STICKY AND UNUSABLE. THE PROCEDURE WAS PROLONGED BUT ULTIMATELY COMPLETED WITH A ANOTHER ROTAWIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568165 ↗
• MalfunctionNov 17, 2025Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. FIVE ROTAWIRE DRIVE WIRES WERE SELECTED FOR ROTABLATION. DURING INSERTION, EXCESSIVE COATING WAS OBSERVED ON THE WIRES, CAUSING THE ROTAWIRE ADHERE TO THE BURR. IN DYNAGLIDE MODE, THE WIRE WAS UNABLE TO ADVANCE NORMALLY. IT WAS LATER NOTED THAT THE FIRST WIRE HAD ACCUMULATED MULTIPLE FIBERS FROM THE DRAPE, FORMING A BALL OF FLUFF THAT ADVANCED TOWARD THE CORONARY ARTERY. ATTEMPTS TO USE THE REMAINING FOUR WIRES YIELDED SIMILAR RESULTS. THE FINAL WIRE SEIZED WITHIN THE BURR, APPEARING TO HAVE FIBERS ADHERED TO IT AS IF BY GLUE. DESPITE MULTIPLE ATTEMPTS TO CLEAN THE WIRE, INCLUDING WIPING IT END-TO-END APPROXIMATELY TEN TIMES AND MANUALLY REMOVING THE LUMPS, THE WIRE REMAINED STICKY AND UNUSABLE. THE PROCEDURE WAS PROLONGED BUT ULTIMATELY COMPLETED WITH A ANOTHER ROTAWIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568159 ↗
• MalfunctionNov 17, 2025Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. FIVE ROTAWIRE DRIVE WIRES WERE SELECTED FOR ROTABLATION. DURING INSERTION, EXCESSIVE COATING WAS OBSERVED ON THE WIRES, CAUSING THE ROTAWIRE ADHERE TO THE BURR. IN DYNAGLIDE MODE, THE WIRE WAS UNABLE TO ADVANCE NORMALLY. IT WAS LATER NOTED THAT THE FIRST WIRE HAD ACCUMULATED MULTIPLE FIBERS FROM THE DRAPE, FORMING A BALL OF FLUFF THAT ADVANCED TOWARD THE CORONARY ARTERY. ATTEMPTS TO USE THE REMAINING FOUR WIRES YIELDED SIMILAR RESULTS. THE FINAL WIRE SEIZED WITHIN THE BURR, APPEARING TO HAVE FIBERS ADHERED TO IT AS IF BY GLUE. DESPITE MULTIPLE ATTEMPTS TO CLEAN THE WIRE, INCLUDING WIPING IT END-TO-END APPROXIMATELY TEN TIMES AND MANUALLY REMOVING THE LUMPS, THE WIRE REMAINED STICKY AND UNUSABLE. THE PROCEDURE WAS PROLONGED BUT ULTIMATELY COMPLETED WITH A ANOTHER ROTAWIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568158 ↗
• MalfunctionOct 21, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR GOT STUCK WITH THE ROTA WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM ROTAPRO AND A 5 PACK NG ROTAWIRE EXTRA SUPPORT WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING INSERTION, IT WAS NOTED THAT THE BURR GOT STUCK WITH THE ROTA WIRE. THE SET ROTATION SPEED WAS AT 190,000 RPM BUT THE MAXIMUM SPEED WAS ONLY AT 180,000 RPM. THE STUCK COULD NOT BE RELEASED, SO THE ROTA BURR WAS REMOVED OUTSIDE THE PATIENT TOGETHER WITH THE ROTA WIRE AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351081 ↗
• MalfunctionSep 3, 2025Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT BE FIXED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN TRUNK. A ROTALINK ADVANCER AND A ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE ROTALINK ADVANCER AS NOT COMPATIBLE WITH THE DRIVE GUIDEWIRE. THERE WERE ABNORMAL NOISES AT LOW AND HIGH SPEEDS. MOREOVER, WHEN THE TAIL CLIP WAS PROPERLY CLAMPED, THE GUIDEWIRE COULD NOT BE FIXED, WHEN THE BURR WAS MOVING AT A LOW SPEED, THE GUIDE WIRE HAD THE TENDENCY TO MOVE FORWARD OR BACKWARD, AND THE GUIDEWIRE SYSTEM WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS NOT LOCKED DURING ADVANCEMENT AND PULLBACK OF THE BURR. THE ABNORMAL NOISES COMING FROM THE ADVANCER WAS FURTHER DESCRIBED AS "SCREECHY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956661 ↗
• MalfunctionAug 19, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ROTAPRO BURR BECAME STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT MAIN TRUNK (LMT). A 1.50MM ROTAPRO AND A ROTAWIRE WERE SELECTED FOR USE. DURING INSERTION, IT WAS NOTED THAT THE ROTAPRO BURR BECAME STUCK WITH THE ROTAWIRE. IT WAS NOT RELEASED FROM BEING STUCK, AND THE ROTAPRO BURR WAS REMOVED FROM THE BODY TOGETHER WITH THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURY AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843834 ↗
• InjuryJul 25, 2025Nonstandard Device; Detachment of Device or Device Component; Difficult to Advance; Nonstandard Device; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE ROTAWIRE BECAME DETACHED AND EMERGENCY SURGERY WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A ROTAWIRE DRIVE AND A 1.50MM ROTAPRO WERE SELECTED FOR USE. DURING THE PROCEDURE, UPON ADVANCING THE DEVICE IN A DYNAGLIDE MODE INTO THE LESION, RESISTANCE WAS FELT NEAR THE NON-BSCI GUIDE CATHETER OUTLET. CONSECUTIVELY, THE WIRE BECAME DETACHED AND PERFORATED THE ARTERY. HEMOSTASIS COULD NOT BE ACHIEVED AFTER VARIOUS MEASURES WERE TAKEN, REQUIRING ADDITIONAL SURGERY TO BE PERFORMED, AND THE WIRE FRAGMENT WAS REMOVED. IT WAS THOUGHT THAT THE GUIDE CATHETER DEFORMATION WAS DUE TO THE TRANSCATHETER AORTIC VALVE (TAVI) JAILING THE CORONARY ARTERY THAT CAUSES THE VERY HIGH RESISTANCE, LEADING TO THE DETACHMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 90-99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. DURING THE PROCEDURE, THE SPEED WAS SET TO 180,000RPM. HOWEVER, A HIGH ABNORMAL SOUND WAS HEARD IN THE GUIDING CATHETER.

  Patient problems: Perforation

  MAUDE report 22609895 ↗
• MalfunctionJul 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE PATIENT PRESENTED WITH STABLE ANGINA. A ROTAWIRE DRIVE WAS SELECTED FOR USE, HOWEVER, UPON OPENING THE PACKAGE, FOREIGN MATERIAL WAS OBSERVED ON THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTAWIRE DRIVE. THERE WERE NO PATENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553763 ↗
• MalfunctionJun 11, 2025Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ROTAPRO BURR BECAME STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A 1.50MM ROTAPRO AND ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THE ROTAWIRE COULD NOT BE REMOVED AFTER DYNAGLIDE ABLATION. IT WAS BELIEVED THAT THE ROTAWIRE WAS KINKED. THE ROTAPRO BURR BECAME STUCK WITH THE ROTAWIRE. THE ROTAPRO BURR WAS REMOVED OUTSIDE THE PATIENT TOGETHER WITH THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184041 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P900056. One submission often covers many models, so check the product and lot details in each record.

• Z-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• Z-0212-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rota
• Z-0211-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator