Euphora™ EUP3015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169560154), received between Jan 31, 2017 and Feb 10, 2026 — classified as 1 death, 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (6 reports).

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

1 other recall cover devices cleared under the same FDA submission (K143480); 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 16, 2026.

Recalls naming this device

1. Sep 3, 2019Open, Classified

   Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

   Z-0122-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 13, 2017Terminated

   Stylette removal difficulties on the Euphora and Solarice products.

   Z-3136-2017 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Burst Container or Vessel; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON CATHETER, DURING INFLATION THE BALLOON RUPTURED WHILE POST DILATING A STENT AT 22 ATM. THIS EUPHORA BALLOON WAS USED FOR PRE-DILATION OF THE LESION AND WAS THEN REINSERTED TO POST-DILATE THE STENT. THE LESION BEING TREATED WAS MILDLY TORTUOUS, MILDLY CALCIFIED WITH 95% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. DURING REMOVAL OF THE DEVICE, A DETACHMENT OCCURRED AT THE BALLOON. THE DETACHED PORTION OF DEVICE REMAINS IN PATIENT. A 3.0 STENT WAS PLACED TO TRAP THE BALLOON MATERIAL BETWEEN THE STENT AND THE ARTERIAL WALL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24303932 ↗
• InjuryDec 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA DEVICE TO TREAT A NON TORTUOUS, NON CALCIFIED LESION. NO DAMAGE WAS NOTED TO THE PACKAGING, AND THE DEVICE WAS REMOVED FROM THE HOOP WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE CATHETER DETACHED, CRACKED OR FRACTURED DURING REMOVAL OF THE DEVICE. THE DEVICE WAS NOT KINKED AND RE STRAIGHTENED DURING USE. IT WAS STATED THAT THE DEVICE DOES NOT REMAIN IN THE PATIENT, THAT IT WAS SNARED OUT. IT WAS STATED THAT THE BALLOON WAS USED AS A TRAPPING BALLOON AND WAS NEVER PLACED IN AN ARTERY. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15957868 ↗
• MalfunctionAug 29, 2022Deflation Problem; Deflation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. 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 BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON, WIRE, AND CATHETER WERE RETRACTED TOGETHER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15309200 ↗
• MalfunctionMar 23, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED AT THE MID/OSTIUM LEFT MAIN (LM) CORONARY ARTERY/RAMUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE DETACHED, CRACKED, OR FRACTURED AT THE CATHETER. IT WAS STATED THAT THE SHAFT OF THE DEVICE FRACTURED WITHIN THE GUIDE CATHETER WHEN TRYING TO PULL THE DEVICE OUT OF THE GUIDE. IT WAS STATED THAT THE BALLOON WAS BEING USED TO TRAP A .014'' WIRE IN THE GUIDE CATHETER. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13868892 ↗
• MalfunctionDec 2, 2020Deflation Problem; Deflation Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ON EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS STATED THAT THE BALLOON WAS SAFELY REMOVED FROM THE PATIENT WHILE STILL INFLATED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934306 ↗
• MalfunctionMar 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A MODERATELY TORTUOUS LESION EXHIBITING 50% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO ISSUES NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS NOT INSPECTED. THE LESION WAS NOT PRE-DILATED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE DETACHED AT THE CATHETER DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. IT WAS STATED THAT THE PATIENT HAD INSTENT RESTENOSIS IN THE MID LAD. A WIRE WAS PASSED THROUGH THE LESION AND OCT WAS PERFORMED. IT WAS STATED THAT THE OCT OR WIRE MAY HAVE GOT CAUGHT ON THE PREVIOUSLY IMPLANTED STENT. IT WAS REPORTED THAT A NON-MEDTRONIC BALLOON CAUGHT THE VESSEL AFTER BALLOONING. IT WAS INDICATED THAT THE NON-MEDTRONIC BALLOON BROKE FROM THE SHAFT IN THE GUIDE CATHETER DURING REMOVAL. THE 3.0 X 15 EUPHORA RX WAS THEN ATTEMPTED TO BE USED TO TRAP THE PARTS OF THE NON-MEDTRONIC BALLOON AND IT ALSO BROKE AT THE SHAFT. A SNARE WAS USED TO TRAP THE 3.0 X 15 EUPHORA RX (LOT NUMBER 218711917) AND ALL PIECES WERE REMOVED FROM THE PATIENTS BODY. IT WAS NO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9903377 ↗
• DeathMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. A EUPHORIA BALLOON CATHETER WAS ALSO USED. APPROXIMATELY 7 MONTHS LATER THE PATIENT SUFFERED HOSPITAL ACQUIRED PNEUMONIA TREATED WITH HOSPITALIZATION AND EPINEPHRINE AND A CHEST TUBE. THE PATIENT DIED . CAUSE OF DEATH WAS CARDIAC ARREST. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE.

  Patient problems: Death; Pneumonia

  MAUDE report 9852399 ↗
• InjuryMar 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A MODERATELY TORTUOUS LESION EXHIBITING 50% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO ISSUES NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS NOT INSPECTED. THE DEVICE WAS NOT PRE-DILATED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE DETACHED AT THE CATHETER DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. IT WAS STATED THAT THE PATIENT HAD INSTENT RESTENOSIS IN THE MID LAD. A WIRE WAS PASSED THROUGH THE LESION AND OCT WAS PERFORMED. IT WAS STATED THAT THE OCT OR WIRE MAY HAVE GOT CAUGHT ON THE PREVIOUSLY IMPLANTED STENT. IT WAS REPORTED THAT A NON MEDTRONIC BALLOON CAUGHT THE VESSEL AFTER BALLOONING. DURING THE REMOVAL, THE NON MEDTRONIC BALLOON BROKE FROM THE SHAFT. THE 3.0 X 15 EUPHORA RX WAS THEN ATTEMPTED TO BE USED AND IT ALSO BROKE AT THE SHAFT. IT WAS NOTED THAT SEVERAL OTHER BALLOONS WERE USED INCLUDING A 2.5 X 15 EUPHORA RX. THERE WAS NO ISSUES NOTED WITH THE 2.5 X 15 EUPHORA RX. A SNARE WAS USED TO TRAP THE BALLOON AND ALL PIECES WERE REMOVED FROM THE PATIE

  Patient problems: Injury

  MAUDE report 9822474 ↗
• MalfunctionJul 23, 2019Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  DURING A PROCEDURE A EUPHORA RX PTCA BALLOON CATHETER WAS USED TO PRE-DILATE A MILDLY TORTUOUS AND CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE AND WAS THEREFORE PULLED INTO THE AORTA AND POPPED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8815045 ↗
• MalfunctionJun 12, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER, AN NC EUPHORA RX PTCA BALLOON CATHETER, AND A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS, SEVERELY CALCIFIED LESION IN OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED USING A CUTTING BALLOON. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED DURING DELIVERY OF THE NC EUPHORA AND THE RESOLUTE ONYX DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF ALL THREE DEVICES. IT WAS REPORTED THAT ALL THREE DEVICES BURST WHEN INFLATED TO 12 ATM. THE RESOLUTE ONYX BURST DURING STENT DEPLOYMENT. ONE INFLATION HAD BEEN APPLIED TO THE RESOLUTE ONYX PRIOR TO THE BURST. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690528 ↗
• MalfunctionMay 29, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AND ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER AND A NANOCROSS 0.14 OTW PTA DILATATION CATHETER TO TREAT A MODERATE CALCIFIED, MODERATE TORTUOSITY LESION EXHIBITING 100% CHRONIC TOTAL OCCLUSION IN THE MID RIGHT TIBIAL/POPLITEAL TRUNK. THE EUPHORA BALLOON WAS INSPECTED WITH NO ISSUES NOTED, NEGATIVE PREP WAS PERFORMED ON THE EUPHORA BALLOON WITH NO ISSUES. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED, EXCESSIVE FORCE WAS NOT USED. NO EMBOLIC PROTECTION WAS USED ON THE NANOCROSS 0.14 OTW. THERE WAS NO ISSUES NOTED REMOVING NANOCROSS 0.14 OTW FROM THE HOOP/TRAY. THE NANOCROSS 0.14 OTW WAS PREPPED AS PER THE IFU WITH NO ISSUES NOTED. IT IS REPORTED THAT BOTH BALLOONS BURST/RUPTURED ON THE INITIAL INFLATION AT APPROX. 8ATM. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8649022 ↗
• MalfunctionJul 24, 2018Inflation Problem; Material Puncture/Hole

  A EUPHORA BALLOON CATHETER WAS INTENDED TO BE USED TO TREAT A LESION. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. NEGATIVE PREP/PURGING WAS PERFORMED ON THE DEVICE PRIOR TO USE WITH NO ISSUES NOTED. IT IS REPORTED THAT DURING THE INFLATION OF A EUPHORA BALLOON CATHETER, THE DOCTOR REALIZED THAT THE BALLOON INFLATED PARTIALLY, BUT WAS NOT INFLATING FULLY. THE PHYSICIAN THOUGHT THERE WAS A HOLE, SO THEY REMOVED IT FROM THE PATIENT'S BODY. WHEN IT WAS REMOVED HE INFLATED IT AND CONFIRMED THAT THERE WAS A HOLE. IT IS NOT KNOWN IF THE HOLE WAS PRESENT PRIOR TO USE, FROM PREPPING OR FROM INSERTION. THE PROCEDURE WAS COMPLETED WITH A NEW 3.0X15MM EUPHORA. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7713275 ↗
• MalfunctionJun 9, 2017Deflation Problem; Inflation Problem; Detachment of Device or Device Component; Deflation Problem; Inflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA BALLOON CATHETER TO TREAT A NON -TORTUOUS PROXIMAL RCA LESION. NO DAMAGE WAS NOTED TO DEVICE PACKAGING AND NO ISSUES REMOVING DEVICE FROM HOOP. DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THAT THE BALLOON INFLATED SLOWLY DURING FIRST INFLATION. THE PHYSICIAN TOOK THE BALLOON BACK DOWN AND APPLIED SOME NEGATIVE PRESSURE AGAIN AND THEN TRIED TO TAKE IT BACK UP TO NOMINAL. THE BALLOON INFLATED BUT THEN WOULD NOT DEFLATE. THE PHYSICIAN CAPTURED THE BALLOON WITH THE GUIDE AND REMOVED THE ENTIRE DELIVERY SYSTEM AND STARTED OVER. THE PROCEDURE WAS CONTINUED AND THE PATIENT RECEIVED A RESOLUTE STENT WITH SUCCESSFUL OUTCOME AND NO PATIENT INJURY. THE PHYSICIAN STATED THAT THE BALLOON COMPLETELY FAILED TO WORK PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6629105 ↗
• MalfunctionMay 10, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA RX BALLOON TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS MID LAD LESION EXHIBITING 90 % STENOSIS. NO DAMAGE TO DEVICE PACKAGING OR ISSUES REMOVING THE DEVICE FROM THE HOOP. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH / PACKAGING STYLETTE FROM THE DEVICE. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE OR EXCESSIVE FORCE USED. THERE WERE NO INFLATION DIFFICULTIES. PRESSURE OF 14 ATM WAS APPLIED. IT WAS REPORTED THAT USUALLY A 50/50 CONCENTRATION OF CONTRAST / SALINE IS USED HOWEVER THERE COULD HAVE BEEN HIGHER RATIO OF CONTRAST DRAWN. THE DEVICE FAILED TO DEFLATE AT THE LESION SITE ON THE FIRST DEFLATION. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. THE BALLOON AND GUIDE CATHETER WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556341 ↗
• MalfunctionJan 31, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A NC EUPHORA BALLOON TO PRE-DILATE A MODERATELY CALCIFIED AND NON-TORTUOUS PROXIMAL LAD LESION EXHIBITING 99% STENOSIS. NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH / PACKAGING STYLETTE FROM THE DEVICE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT CONTRAST WAS INITIALLY SPILLED ON THE DRAPE AND THE RN ASPIRATED THE CONTRAST INTO A 30 CC SYRINGE AND THEN USED THAT SYRINGE TO PREP THE BALLOON. THE 30/70 CONTRAST/SALINE WAS USED. NO GAUZE OR DRAPE FIBRE WAS NOTED IN THE CONTRAST. THE PHYSICIAN NOTED THAT THE BALLOON WAS ACCIDENTALLY KINKED WHILE LOADING ON THE WIRE. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE BALLOON DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED WITH SLOW INFLATION NOTED. BALLOON DEFLATION DIFFICULTIES WERE ALSO ENCOUNTERED AFTER THE FIRST INFLATION. THE DEVICE WAS NOT MOVED OR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6289265 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143480. One submission often covers many models, so check the product and lot details in each record.

• Z-3137-2017 · Jul 13, 2017 · Terminated
  Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.