MICROTEK 1 (UDI 00748426073337)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00748426073337), received between Mar 23, 2018 and Apr 23, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (4 reports).

8 other recalls cover devices cleared under the same FDA submission (K882724); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 23, 2018Hole In Material; Hole In Material

  MEDWATCH REPORT WAS RECEIVED ON (B)(6) 2018 WITH THE FOLLOWING INFORMATION: OVER THE PAST WEEK OR SO, THE OR NOTICED 4 SURGICAL PROBE COVERS THAT HAVE PIN HOLES. 4 DRAPES WERE SAVED, 3 PATIENT INFORMATION AVAILABLE (4TH DRAPE CAME WITH NO PATIENT INFORMATION). LOT NUMBERS ON 2 CASES CAN BE CONFIRMED AS SAME AND THE 3RD HAS A DIFFERENT LOT NUMBER. REFERENCE NUMBERS SAME ON THREE (A FOURTH DRAPE DOES NOT HAVE ANY MANUFACTURER/DEVICE INFORMATION). THIS DEVICE WAS NOTED TO HAVE BLOOD SEEPAGE INTO PROBE - IT IS BELIEVED THAT THE PROBE TOUCHED PATIENT'S SKIN DUE TO SMALL SIZE OF HOLE. 2 OF THE CASES WERE SENTINEL NODES BEING RETRIEVED AND PIN HOLES NOTED IN PROBE COVER WHEN CHECKED WITH SALINE AFTER THE CASE. A THIRD CASE WAS A BREAST BIOPSY. NO CASE DELAYS. NO PATIENT HARMS NOTED TO THIS POINT. OR TEAM KEEPING AN EYE ON ANY MORE PROBE COVERS WITH SIMILAR ISSUES. INTEGRITY OF STERILITY IS OR TEAM'S CONCERN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7452116 ↗
• MalfunctionApr 23, 2018Hole In Material; Hole In Material

  MEDWATCH REPORT WAS RECEIVED ON 3/28/2018 WITH THE FOLLOWING INFORMATION: OVER THE PAST WEEK OR SO, THE OPERATING ROOM (OR) NOTICED 4 SURGICAL PROBE COVERS THAT HAVE PIN HOLES. FOUR (4) DRAPES WERE SAVED, 3 PATIENT INFORMATION AVAILABLE (4TH DRAPE CAME WITH NO PATIENT INFORMATION). LOT NUMBERS ON 2 CASES CAN BE CONFIRMED AS SAME AND THE 3RD HAS A DIFFERENT LOT NUMBER. REFERENCE NUMBERS SAME ON THREE (A FOURTH DRAPE DOES NOT HAVE ANY MANUFACTURER/DEVICE INFORMATION). THIS DEVICE WAS NOTED TO HAVE BLOOD SEEPAGE INTO PROBE - IT IS BELIEVED THAT THE PROBE TOUCHED PATIENT'S SKIN DUE TO SMALL SIZE OF HOLE. TWO (2) OF THE CASES WERE SENTINEL NODES BEING RETRIEVED AND PIN HOLES NOTED IN PROBE COVER WHEN CHECKED WITH SALINE AFTER THE CASE. A THIRD CASE WAS A BREAST BIOPSY. NO CASE DELAYS. NO PATIENT HARMS NOTED TO THIS POINT. OR TEAM KEEPING AN EYE ON ANY MORE PROBE COVERS WITH SIMILAR ISSUES. INTEGRITY OF STERILITY IS OR TEAM'S CONCERN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451916 ↗
• MalfunctionApr 23, 2018Hole In Material; Hole In Material

  MEDWATCH REPORT WAS RECEIVED ON 3/28/2018 WITH THE FOLLOWING INFORMATION: OVER THE PAST WEEK OR SO, THE OR NOTICED 4 SURGICAL PROBE COVERS THAT HAVE PIN HOLES. 4 DRAPES WERE SAVED, 3 PATIENT INFORMATION AVAILABLE (4TH DRAPE CAME WITH NO PATIENT INFORMATION). LOT NUMBERS ON 2 CASES CAN BE CONFIRMED AS SAME AND THE 3RD HAS A DIFFERENT LOT NUMBER. REFERENCE NUMBERS SAME ON THREE (A FOURTH DRAPE DOES NOT HAVE ANY MANUFACTURER/DEVICE INFORMATION). THIS DEVICE WAS NOTED TO HAVE BLOOD SEEPAGE INTO PROBE - IT IS BELIEVED THAT THE PROBE TOUCHED PATIENT'S SKIN DUE TO SMALL SIZE OF HOLE. 2 OF THE CASES WERE SENTINEL NODES BEING RETRIEVED AND PIN HOLES NOTED IN PROBE COVER WHEN CHECKED WITH SALINE AFTER THE CASE. A THIRD CASE WAS A BREAST BIOPSY. NO CASE DELAYS. NO PATIENT HARMS NOTED TO THIS POINT. OR TEAM KEEPING AN EYE ON ANY MORE PROBE COVERS WITH SIMILAR ISSUES. INTEGRITY OF STERILITY IS OR TEAM'S CONCERN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7451142 ↗
• MalfunctionMar 23, 2018Hole In Material

  OVER PAST WEEK OR SO, THE OR NOTICED 4 SURGICAL PROBE COVERS THAT HAVE PIN HOLES. FOUR DRAPES WERE SAVED, 3 PATIENT INFORMATION AVAILABLE (4TH DRAPE CAME WITH NO PATIENT INFORMATION). LOT NUMBERS ON 2 CASES CAN BE CONFIRMED AS SAME AND THE 3RD HAS A DIFFERENT LOT NUMBER. REFERENCE NUMBERS SAME ON THREE (A FOURTH DRAPE DOES NOT HAVE ANY MANUFACTURER/DEVICE INFORMATION). THIS DEVICE WAS NOTED TO HAVE BLOOD SEEPAGE INTO PROBE; IT IS BELIEVED THAT THE PROBE TOUCHED PATIENT'S SKIN DUE TO SMALL SIZE OF HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365361 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K882724. One submission often covers many models, so check the product and lot details in each record.

• Z-0753-2017 · Nov 30, 2016 · Terminated
  Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
• Z-0974-2014 · Jul 12, 2013 · Terminated
  5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the orde
• Z-0946-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
• Z-0943-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
• Z-0944-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS
• Z-0947-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
• Z-0948-2014 · Jul 2, 2013 · Terminated
  Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
• Z-0945-2014 · Jul 2, 2013 · Terminated
  MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS