Micro Access 06507201Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787065072010), received between Jul 12, 2016 and Nov 12, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K051655); 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.

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.

• MalfunctionNov 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH A .018 45CM GUIDEWIRE. DURING A PROCEDURE, WHEN PULLING THE GUIDEWIRE THROUGH TO REMOVE IT, THE TIP BROKE OFF. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10828356 ↗
• InjuryDec 5, 2019Material Frayed; Difficult to Advance; Physical Resistance/Sticking

  MEDWATCH REPORT MW5090799 WAS RECEIVED NOVEMBER 18 2019. NO IDENTIFYING CUSTOMER INFORMATION WAS PROVIDED. ON (B)(6) 2019, A PATIENT WITH CRITICAL AS WAS TAKEN TO THE CATH LAB S/P CARDIAC ARREST AND ECMO PLACEMENT FOR RIGHT HEART CATH, AND PLACEMENT OF ARTERIAL LINE, SWAN-GANZ (SG) CATHETER, AND RETROGRADE REPERFUSION CANNULAS. ADVANCEMENT OF THE SG MICROWIRE WAS A BIT DIFFICULT AND FACED WITH RESISTANCE. THE WIRE WAS DRAWN BACK AND ABLE TO BE PULLED OUT OF THE NEEDLE BUT IT CAME OUT FRAYED. AT THAT POINT, THE DECISION WAS MADE TO WITHDRAW THE REMAINING WIRE AND NEEDLE IN ONE FASHION. CONSULTATION WITH INTERVENTIONAL CARDIOLOGY, CRITICAL CARE PHYSICIAN AND INTERVENTIONAL RADIOLOGY, AND CARDIOTHORACIC SURGERY OCCURRED. IT WAS DETERMINED THAT THIS WAS A SHORT TIP OF THE PLATINUM WIRE IN THE VENOUS SYSTEM AND THAT AT THE CURRENT STATE, GIVEN THE PATIENT'S CARDIOGENIC SHOCK, ECMO STATUS, THAT NO FURTHER INTERVENTION WOULD BE DONE AT THAT TIME. THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Cardiogenic Shock

  MAUDE report 9415580 ↗
• InjuryNov 18, 2016Break; Crack; Uncoiled; Break; Crack; Uncoiled

  RECEIVED USER MEDWATCH MW5065175 ON OCTOBER 25, 2016. AS REPORTED: A PATIENT WITH A HISTORY OF PERIPHERAL ARTERIAL DISEASE WAS TAKEN TO THE CATH LAB FOR PERIPHERAL ARTERIOGRAM AND POSSIBLE INTERVENTION. THE MICROPUNCTURE NEEDLE WAS INTRODUCED VIA THE RIGHT GROIN INTO THE ARTERIAL BASE VIA MODIFIED SELDINGER APPROACH WITH A SINGLE ANTERIOR WALL STICK. THE MICROPUNCTURE WIRE WAS PACKED INTO THE MICROPUNCTURE NEEDLE WHERE UPON UNDER FLUOROSCOPY, WAS NOTED TO BE COILED. ATTEMPT WAS MADE TO EXTRACT THE WIRE USING GENTLE TRACTION, RESULTING IN THE UNRAVELING OF THE WIRE TIP WITH RETAINED FOREIGN BODY. THE RETAINED WIRE WAS SUCCESSFULLY EXTRACTED FROM THE RIGHT GROIN VIA INCISION INTO THE SUBCUTANEOUS TISSUE WITHOUT ANY COMPLICATIONS. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6112402 ↗
• InjuryJul 12, 2016Crack; Fracture; Crack; Fracture

  AS REPORTED ON JUNE 07, 2016, A(B)(6), MALE PATIENT PRESENTED FOR AN FEMORAL VEIN VENOGRAM FOR A DVT IN THE RIGHT CALF. DURING THE PROCEDURE, THE PHYSICIANS WERE INSERTING A .018 X 45 CM STAINLESS STEEL GUIDE WIRE. FIRST THEY ATTEMPTED TO ACCESS THE RIGHT POSTERIOR TIBIAL VEIN UNDER ULTRASOUND GUIDANCE AND AFTER SEVERAL ATTEMPTS THEY WERE UNSUCCESSFUL. THEN THEY ATTEMPTED TO ACCESS THE RIGHT POPLITEAL VEIN AND AFTER MULTIPLE ATTEMPTS WERE NOT SUCCESSFUL. DURING WITHDRAWAL OF THE GUIDEWIRE, IT WAS NOTED THE GUIDEWIRE TIP HAD FRACTURED OFF INSIDE OF THE PATIENT. THE PHYSICIANS DID NOT ATTEMPT TO REMOVAL OF THE GUIDEWIRE FRAGMENT AS IT WAS EMBEDDED AND NO THREAT TO THE PATIENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5785077 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051655. One submission often covers many models, so check the product and lot details in each record.

• Z-0418-2021 · Oct 14, 2020 · Terminated
  Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H7870
• Z-0773-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046
• Z-0775-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051
• Z-0774-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050
• Z-0777-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 0659
• Z-0772-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 0659703
• Z-0778-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular s
• Z-0776-2017 · Sep 28, 2016 · Terminated
  ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 0659
• Z-1405-2013 · Apr 30, 2013 · Terminated
  AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standar