First ChoiceRecalls & reported problems across all models

We found 9 models of First Choice by Creagh Medical Limited in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2018 and Sep 12, 2025 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported First Choice problems

First Choice models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• First Choice EUHP75124

  Catheter, Angioplasty, Peripheral, Transluminal
  5 reports
• First Choice UHP7584

  Catheter, Angioplasty, Peripheral, Transluminal
  4 reports
• First Choice EUHP75144

  Catheter, Angioplasty, Peripheral, Transluminal
  3 reports
• First Choice UHP7588

  Catheter, Angioplasty, Peripheral, Transluminal
  3 reports
• First Choice UHP7574

  Catheter, Angioplasty, Peripheral, Transluminal
  2 reports
• First Choice UHP75104

  Catheter, Angioplasty, Peripheral, Transluminal
  2 reports
• First Choice UHP7564

  Catheter, Angioplasty, Peripheral, Transluminal
  1 report
• First Choice UHP7594

  Catheter, Angioplasty, Peripheral, Transluminal
  1 report
• First Choice EUHP75164

  Catheter, Angioplasty, Peripheral, Transluminal
  1 report

Recent First Choice adverse event reports

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

• MalfunctionSep 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE BALLOON CATHETER WAS USED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE SITE REPORTED THE BALLOON BROKE WHILE INSIDE THE PATIENT. THE PROVIDED IMAGE AND VIDEO CLIP CONFIRMED THE BALLOON CATHETER SEPARATED MID-BALLOON. THE DISTAL SEGMENT CONTAINED THE TIP, MARKER BAND, PART OF THE INNER LUMEN, AND PART OF THE BALLOON. NO SEGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER BALLOON. THERE WAS NO PATIENT INJURY. THE SITE WAS QUERIED FOR ADDITIONAL INFORMATION WITHOUT RECEIVING A RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23045758 ↗
• InjurySep 23, 2024Fracture; Off-Label Use; Material Separation; Fracture; Off-Label Use; Material Separation

  THE PATIENT PRESENT FOR A FISTALGRAM AND ANGIOPLASTY PROCEDURE. IT WAS DETERMINED THE CEPHALIC ARCH WAS APPROXIMATELY 80% STENOSED. THE HIGH PRESSURE BALLOON INFLATIONS WERE PERFORMED. MODERATE WASTE NOTED, FOLLOWED BY FULL EFFACEMENT AT 22ATM. THE BALLOON WAS DEFLATED AND EASILY REMOVED. THE STENOSIS WAS REEVALUATED WITH CONTRAST INJECTION. SIGNIFICANT STENOSIS PRESENCE WAS IDENTIFIED AND STENT PLACEMENT WAS PERFORMED. THE BALLOON WAS ADVANCED OVER WIRE AND INFLATIONS PERFORMED. THE BALLOON WAS USED TO FULLY EXPAND THE STENT AND SET IN PLACE AGAINST THE VESSEL WALL. THE INTENTION WAS TO INFLATE THE BALLOON TO 20ATM. HOWEVER, THE BALLOON RUPTURED AT 16ATM. THE BALLOON WAS DIFFICULT TO REMOVE AS IT APPEARED TO BE STUCK TO NEWLY PLACED STENT. WITH MUCH DIFFICULTY BALLOON WAS ABLE TO BE PULLED FOLLOWED BY SHEATH REMOVAL. EXAMINATION OF THE BROKEN BALLOON WAS THEN PERFORMED. THE BALLOON WAS DETERMINED TO HAVE RUPTURED TRANSVERSELY WITH HALF OUT OF THE BODY AND OTHER HALF REMAINING INSIDE. THE REMAINING BALLOON WAS ULTIMATELY ABLE TO BE REMOVED OVER THE WIRE WITH FORCE. FOLLOWING BALLOON REMOVAL, THE GUIDEWIRE WAS ABLE TO MOVE FREELY. UNDER HIGH MAGNIFICATION AREA OF SHEATH WAS PRESENT

  Patient problems: Foreign Body In Patient

  MAUDE report 20285557 ↗
• MalfunctionApr 25, 2024Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR INDICATED THE TARGET VESSEL HAD NO CALCIFICATION WITH APPROXIMATELY 80% STENOSIS. THE LESION LENGTH WAS NOT PROVIDED. IT WAS CONFIRMED THE BALLOON RUPTURED DURING INITIAL INFLATION TO 14ATM INSIDE OF A STENT. THERE WAS NO PATIENT HARM. THE EVENT RESULTED IN A PROCEDURE DELAY OF APPROXIMATELY 5 MINUTES. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS IN STABLE CONDITION. PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183197 ↗
• MalfunctionSep 1, 2023Fracture; Fracture

  DURING A LEFT ARM FISTULA ANGIOPLASTY PROCEDURE, THE BALLOON BURST WITHOUT MUCH PRESSURE BEING APPLIED. THE BALLOON BURST OCCURRED DURING INITIAL INFLATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER BALLOON. THERE WAS NO IMPACT TO PATIENT OUTCOME. THE PATIENT WAS DISCHARGED WITHOUT ISSUE. THERE WAS NO VISUAL CALCIFICATION AND THE LESION LENGTH WAS NOT MEASURED. THE VESSEL STENOSIS WAS ESTIMATED TO BE MODERATE. THE INFLATION PRESSURE WAS SAID TO BE LOW, BUT NOT QUANTIFIED BY THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17673736 ↗
• InjuryJul 11, 2023Difficult to Advance; Difficult to Advance

  THE DEVICE WAS USED DURING A FISTULOGRAM PROCEDURE. THE 0.035" HYDROPHILIC GUIDEWIRE WAS PLACED THROUGH A 6FR INTRODUCER SHEATH. THE SITE WAS ABLE TO TRAVERSE TWO LESIONS. HOWEVER, THERE WAS DIFFICULTY LOADING THE BALLOON ONTO THE GUIDEWIRE, DESPITE FLUSHING THE BALLOON SEVERAL TIMES AND MAKING SURE THE GUIDE WIRE WAS MOISTENED AS WELL. THE PHYSICIAN WAS ULTIMATELY ABLE TO LOAD THE BALLOON, BUT WAS ONLY ABLE TO ADVANCE A FEW CENTIMETERS AND THEN WOULD NO LONGER ADVANCE. THE BALLOON WAS REMOVED AND A SECOND BALLOON WAS USED. HOWEVER, THE SECOND BALLOON WOULD ALSO NOT ADVANCE ON THE GUIDEWIRE; ALSO REPORTED AS DEFECTIVE. THE SECOND BALLOON HAD ULTIMATELY FRAYED THE HYDROPHILIC COATING OF THE GUIDEWIRE. THE ISSUE RESULTED IN THE INABILITY OF LOADING ANYTHING ON THE GUIDEWIRE. THE SITE DID NOT HAVE A WIRE CUTTER, SO THE WIRE AND BALLOON WERE REMOVED AND THE SITE HAD TO START OVER. THE SITE WAS THEN UNABLE TO RE-CROSS THE LESIONS. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR THE HOSPITAL OPERATING ROOM WITH AN ANESTHESIOLOGIST. THERE WAS NO REPORTED PROCEDURE DELAY. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298739 ↗
• InjuryJul 11, 2023Difficult to Advance; Difficult to Advance

  THE DEVICE WAS USED DURING A FISTULOGRAM PROCEDURE. THE 0.035" HYDROPHILIC GUIDE WIRE WAS PLACED THROUGH A 6FR INTRODUCER SHEATH. THE SITE WAS ABLE TO TRAVERSE TWO LESIONS. HOWEVER, THERE WAS DIFFICULTY LOADING THE BALLOON ONTO THE WIRE, DESPITE FLUSHING THE BALLOON SEVERAL TIMES AND MAKING SURE THE GUIDE WIRE WAS MOISTENED AS WELL. THE PHYSICIAN WAS ULTIMATELY ABLE TO LOAD THE BALLOON, BUT WAS ONLY ABLE TO ADVANCE A FEW CENTIMETERS AND THEN THE BALLOON WOULD NO LONGER ADVANCE. THE BALLOON WAS REMOVED, AND A SECOND BALLOON WAS USED. HOWEVER, THE SECOND BALLOON WOULD ALSO NOT ADVANCE ON THE GUIDEWIRE; ALSO REPORTED AS DEFECTIVE. THE SECOND BALLOON HAD ULTIMATELY FRAYED THE HYDROPHILIC COATING OF THE GUIDEWIRE. THE ISSUE RESULTED IN THE INABILITY OF LOADING ANYTHING ON THE GUIDEWIRE. THE SITE DID NOT HAVE A WIRE CUTTER, SO THE WIRE AND BALLOON WERE REMOVED, AND THE SITE HAD TO START OVER. THE SITE WAS THEN UNABLE TO RE-CROSS THE LESIONS. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR THE HOSPITAL OPERATING ROOM WITH AN ANESTHESIOLOGIST. THERE WAS NO REPORTED PROCEDURE DELAY. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298372 ↗
• InjuryJun 20, 2023Failure to Deflate; Failure to Deflate

  DURING AN ANGIOPLASTY PROCEDURE, A BALLOON CATHETER WAS USED AND WOULD NOT DEFLATE. THE PATIENT WAS SENT TO THE HOSPITAL TO RESOLVE THE ISSUE. THE FISTULA WAS LOCATED IN THE PATIENT'S ARM IN THE SUBCLAVIAN VEIN. THE LEVEL OF VESSEL CALCIFICATION AND LESION LENGTH WERE UNKNOWN. THE DEGREE OF STENOSIS WAS APPROXIMATELY 50%. THE BALLOON WAS INFLATED TO 14PSI AND PREPPED PER IFU REQUIREMENTS. THE REPORTED ISSUE OCCURRED DURING INITIAL INFLATION. THE PATIENT WAS NOTED TO BE LARGER AND THE PHYSICIAN WAS UNABLE TO LOCATE THE EXACT AREA CONFIDENTLY WITH ULTRASOUND TO DEFLATE THE BALLOON. THE PHYSICIAN THOUGHT IT WOULD BE BETTER FOR THE PATIENT TO GET TO CARE WHERE THEY COULD RECEIVE A CT SCAN. THE BALLOON WAS RUPTURED AT THE HOSPITAL WITHOUT ISSUE AND THE PATIENT RECEIVED DIALYSIS VIA ACCESS. THE PATIENT WAS REPORTED TO BE DOING WELL. THE PATIENT THEN CAME BACK TO THE SITE ON (B)(6) 2023 FOR ADDITIONAL INTERVENTION ON THE ACCESS. THE SECOND PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165762 ↗
• InjuryOct 13, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  DURING A RIGHT UPPER ARM AV ANGIOPLASTY PROCEDURE, A PTA BALLOON BURST DURING INFLATION. THE PATIENT WAS BEING TREATED FOR CENTRAL AND BASILIC VEIN STENOSIS OF AN AV FISTULA. THE BALLOON BURST AT APPROXIMATELY 18ATM, WHICH WAS THE BURST RATE FOR THE DEVICE. THE BALLOON HAD BEEN INFLATED TWO (2) PREVIOUS TIMES PRIOR TO THE BURST AT 18 ATM. A 2MM PORTION OF THE BALLOON (INCLUDING DISTAL MARKER) DETACHED IN VIVO AND MIGRATED TO THE PATIENT'S RIGHT ATRIUM OF THE HEART. ATTEMPTS TO RETRIEVE THE FOREIGN BODY VIA VASCULAR SNARE DEVICE WERE UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO ANOTHER HEALTHCARE FACILITY FOR AN ADDITIONAL RETRIEVAL ATTEMPT. THE ISSUE MAY RESULT IN SURGICAL REMOVAL OF THE FOREIGN BODY IF ALL ENDOVASCULAR ATTEMPTS FAIL. THE FOREIGN BODY HAD NOT MIGRATED ANY FURTHER AT THE MOMENT AND THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15598977 ↗
• MalfunctionApr 15, 2022Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTS WHEN INFLATING BALLOON TO 22PSI, WHICH WAS THE TARGET, THE BALLOON BURST AT 21 PSI. THERE WAS NO PATIENT INJURY REPORTED. MINOR PROCEDURAL DELAYED WAS REPORT WHILE THE NEW DEVICE WAS PREPPED AND INSERTED. THE NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Renal Failure

  MAUDE report 14118608 ↗
• MalfunctionMay 26, 2021Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate; Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate

  DURING PROCEDURE THE BALLOON DID NOT DEFLATE/ REFOLD CORRECTLY. THERE WAS DIFFICULTY IN RETRIEVAL AND GUIDE CATHETER TIP WAS DAMAGED. NO COMPLICATIONS OCCURED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890705 ↗
• MalfunctionMay 26, 2021Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate; Accessory Incompatible; Failure to Fold; Difficult to Open or Close; Mechanical Jam; Failure to Deflate

  DURING PROCEDURE THE BALLOON DID NOT DEFLATE/ REFOLD CORRECTLY. THERE WAS DIFFICULTY IN RETRIEVAL AND GUIDE CATHETER TIP WAS DAMAGED. NO COMPLICATIONS OCCURED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890703 ↗
• MalfunctionMar 11, 2021Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  WHILE PHYSICIAN PERFORMING THE FISTULOGRAM PROCEDURE, THE BALLOON BURST OCCURRED BEFORE REACHING THE BURST RATE, ACCORDING TO THE RATE STATED ON THE PACKAGING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464545 ↗
• MalfunctionDec 16, 2020Difficult to Insert; Mechanical Problem; Material Split, Cut or Torn; Separation Problem; Difficult to Insert; Mechanical Problem; Material Split, Cut or Torn; Separation Problem

  THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT, BUT THEY WERE NOT ABLE TO INSERT THE DEVICE INTO THE PATIENT. THE DEVICE WAS RIPPED DURING THIS PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015427 ↗
• MalfunctionDec 15, 2020Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  THE 12 X 4 X 75 DIRECT ACCESS BALLOON WAS ATTEMPTED TO USE AND NOTICED A SMALL HOLE ON THE BALLOON AND WOULD NOT INFLATE TO ITS FULL POTENTIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015293 ↗
• MalfunctionOct 7, 2020Difficult to Open or Close; Failure to Deflate; Difficult to Open or Close; Failure to Deflate

  FOLLOW UP REPORT FOR CC2020-097-IR; MFR REPORT #: 3005994106-2020-00097.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10645773 ↗

Other Creagh Medical Limited products

• Dynamis AV8 models · 20 reports
• Biotronik Passeo-35 HP9 models · 20 reports