Starter GuidewireRecalls & reported problems across all models

We found 12 models of Starter Guidewire by Lake Region Medical Limited in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Sep 20, 2019 and Sep 30, 2026 — classified as 2 deaths, 29 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Fracture” (41 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 Starter Guidewire problems

Starter Guidewire models

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

• Starter™ Guidewire M001491561

  Wire, Guide, Catheter
  2 deaths116 reports
• Starter™ Guidewire M001491181

  Wire, Guide, Catheter
  7 reports
• Starter™ Guidewire M001491651

  Wire, Guide, Catheter
  4 reports
• Starter™ Guidewire M001491341

  Wire, Guide, Catheter
  3 reports
• Starter™ Guidewire M001491571

  Wire, Guide, Catheter
  2 reports
• Starter™ Guidewire M001491751

  Wire, Guide, Catheter
  2 reports
• Starter™ Guidewire M001492121

  Wire, Guide, Catheter
  2 reports
• Starter™ Guidewire M001491201

  Wire, Guide, Catheter
  1 report
• Starter™ Guidewire M001491381

  Wire, Guide, Catheter
  1 report
• Starter™ Guidewire M001491471

  Wire, Guide, Catheter
  1 report
• Starter™ Guidewire M001491851

  Wire, Guide, Catheter
  1 report
• Starter™ Guidewire M001492251

  Wire, Guide, Catheter
  1 report

Recent Starter Guidewire adverse event reports

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

• MalfunctionSep 30, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948485 ↗
• MalfunctionSep 24, 2026Fracture

  Event Description: We received a defective item; the following information is provided: Product: M001491561 UPN: M001491561 - ROSEN GUIDE 0.035 J TIP 1.5MM Lot Number: 8315979 Model: M001491561 BSC Notification Date: 08/28/2026 Product Available for Return? Yes Note: Guide wire disintegrated upon insertion into the catheter. · What type of procedure was performed? Faraview ablation Date: 08/19/2026 · What was the specific anatomical location? Left atrium · When did the incident occur (e.g., during the procedure, during preparation/before use, etc.)? During the procedure · What was used to complete the procedure (this device, another device of the same type, a different device (different model))? Was another device of the same type used? · Were there any complications for the patient resulting from this event? No · Did the patient's clinical condition remain stable after the procedure? Yes What was the outcome of the procedure (procedure successfully completed, procedure canceled, completed by an alternative method)? Procedure successfully completed. Material is available for analysis. Yes · Please provide the following information about the physician: first and last name, clinic na

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876653 ↗
• MalfunctionSep 24, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876559 ↗
• MalfunctionSep 23, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876472 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Event Description: eCN Event Description: The tension dropped when passing to the right we had time to do the first balloon application before seeing that the tension was much too low and therefore effusion. What troubleshooting steps took place? What troubleshooting steps, if any, resolved the issue?: No troubleshooting needed What is the next course of action?: Just to hear from the patient Patient present at time of event?: Yes Adverse/Unintended Patient Events: Cardiac Tamponade In the physician's opinion, did the device or procedure contribute to the adverse or unintended patient event?: Yes Please explain how the device or procedure contributed?: Because of the J tip Medical or Surgical Interventions: Chest surgery Reason for unsuccessful procedure: The patient's blood pressure has dropped Based on the outcome noted above, was the patient sedated when the procedure was cancelled?: Yes - General Anesthesia Device Acquired from a Distributor?: No.Event Date: 2026-9-7.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50855970 ↗
• MalfunctionSep 16, 2026Contamination

  Event Description: Per CNF, It was reported that: -Event; Damage -Was there any appearance abnormality before use?"[?]" No -At what location and what kind of damage was observed?"[?]" The insulation has peeled off, and the internal wire was exposed. Note: For any Patient Information field(s) left blank in the CNF - 'Asked but not available as per account. In addition, the e-mail address of the physician, who was also the initial reporter, was not available. Physician Comments: Patient Outcome: No Adverse Event Infected: No Generator/controller: Ablation Catheter Used: Other used:Event Date: 2026-8-25

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789673 ↗
• DeathAug 30, 2026Adverse Event Without Identified Device or Use Problem

  Event Description: Per CNF, It was reported that: Event: A patient injury has occurred. Please indicate the details of patient injury observed into the patient: Cardiac Tamponade. Please indicate the details about the event that leads to patient injury. During the BB procedure, there was a pacemaker lead located near the septum, which caused difficulties; after one unsuccessful attempt, the procedure was repeated after repositioning and was successful. During the PVI procedure, the procedure was carried out in the order LS, LI, RI; whilst performing RIPV, it was discovered that the blood pressure was dropping whilst repositioning several times, and treatment for cardiac tamponade was initiated. Please indicate the details about the treatment for the patient injury that occurred. After performing the drainage procedure, information regarding the decision on whether to proceed to surgery is not available. Please indicate the condition of the patient after the treatment. Unknown. Please indicate the view of the attending physician regarding the cause on the occurrence of patient injury. Unknown. Was there a problem with the appearance or functionality of this device? No problem. Was t

  Patient problems: Cardiac Tamponade

  MAUDE report 50514825 ↗
• InjuryAug 18, 2026Entrapment of Device; Difficult to Remove

  eCN Event Description: Ablations performed in Left Pulmonary veins, no issues noted. Physician having issues attempting to wire RPVs. What troubleshooting steps took place? What troubleshooting steps, if any, resolved the issue?: Deployed 'flower' conformation when FARAWAVE catheter partially in sheath. Non-recoverable. What is the next course of action?: New FARAWAVE catheter opened. Patient present at time of event?: Yes

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50298101 ↗
• MalfunctionAug 12, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222369 ↗
• InjuryJul 30, 2026Entrapment of Device

  Device/Procedure Outcome: Procedure Completed,Unable to Use Device - Attempted,Different Device Used (Same Model)Patient Outcome: F26: No Health Consequences or Impact.Event Description: Per CNF, It was reported that: -Event; It was stuck. -Please indicate the details leading up to the event in which it got stuck.; While approaching the LI, the catheter and guidewire did not move at all. When it was forcibly pulled from the body along with the catheter, tissue was found trapped between the catheter and the guidewire. -Please specify the physician's opinion on the cause of the device being stuck; It is possible that the issue was caused by the roof-side portion rubbing against the tissue, as the transition from the flower configuration to the basket configuration was performed within the pulmonary vein in LI. -Please indicate how it was released from being stuck; While approaching the LI, the catheter and guidewire did not move at all. When it was forcibly pulled from the body along with the catheter, tissue was found trapped between the catheter and the guidewire. -Were there any other catheters in the heart when it got stuck?; No -Was the ORION catheter used as a concomitant devic

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50082353 ↗
• MalfunctionJul 29, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077210 ↗
• MalfunctionJul 29, 2026Fracture; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075603 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046662 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50014658 ↗
• InjuryJul 12, 2026Adverse Event Without Identified Device or Use Problem

  ECN EVENT DESCRIPTION: NO EFFUSION ON PRE-PROCEDURE CHECK. TRANSEPTAL PUNCTURE WITH AGILIS SHEATH AND BAYLIS RF WIRE, WAS AS PLANNED DESPITE WIRE ONLY TRACKING RSPV IN THE BEGINNING: CONFIRMED NOT AORTIC WITH BUBBLE VISUALIZATION UPON PUNCTURE, AND WIRE VISUALIZATION WITH ICE AFTER REPOSITIONING INTO THE LSPV. PROCEDURE WENT AS PLANNED COMPLETING PVI WITH OLIVE LESIONS AND PWI WITH FARAWAVE 31 MM CATHETER. THE LSPV WAS THEN WIRED AND A CARDIOVERSION WAS PERFORMED WITH FARAWAVE CATHETER STILL DWELLING INSIDE LEFT ATRIUM. ADDITIONAL LESIONS WERE GIVEN TO LSPV ALONG WITH EXIT BLOCK PACING MANEUVERS AND PHYSICIAN RETRACTED CATHETER INTO AGILIS SHEATH AND ENTIRE SYSTEM WAS RETRACTED INTO RIGHT ATRIUM. PHYSICIAN UTILIZED ICE TO COMPLETE A POST PROCEDURE EFFUSION CHECK AND SAW A SIZABLE EFFUSION ON THE INFERIOR/POSTERIOR RIGHT ATRIUM/RIGHT VENTRICULAR AREA. ATTEMPTS WERE MADE TO COMPLETE A PERICARDIOCENTESIS, HOWEVER, DUE TO BODY HABITUS THE PHYSICIAN WAS UNABLE TO PERFORM AND CARDIOTHORACIC SURGERY WAS CALLED. CARDIOTHORACIC SURGERY SHOWED UP AFTER A 20 MINUTE WAIT AND DECIDED THAT TAKING THE PATIENT TO THE OPERATING ROOM WAS THE BEST CLINICAL DECISION. IN THE OR, A PERICARDIAL WINDOW WA

  Patient problems: Pericardial Effusion

  MAUDE report 25791421 ↗