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NA RF-DGP-LRecalls & reported problems

St. Jude Medical, Inc. · Grounding Pad · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This St. Jude Medical electrosurgical grounding pad has 23 adverse event reports, mostly describing the pad's protective film being assembled the wrong way so a clear layer could remain on the pad and interfere with skin contact. Reports mention 2 injuries, including burns, and no deaths. The device was recalled in October 2019 for this manufacturing issue; that recall is now closed.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
23
Deaths reported
0
Injuries reported
2
Recalls naming it
1

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05415067028914), received between Jun 25, 2019 and Oct 15, 2019 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (21 reports).

1 FDA recall record name this device's identifier.

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. Oct 14, 2019Terminated

    Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.

    Z-0664-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Material Deformation21
  • Material Separation2

Patient problems

  • No Patient Involvement18
  • Burn(s)2
  • No Consequences Or Impact To Patient2
  • Superficial (First Degree) Burn1

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 15, 2019Material Deformation; Material Deformation

    THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9191967 ↗
  • MalfunctionOct 15, 2019Material Deformation; Material Deformation

    THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9191955 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950659 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950646 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950644 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950643 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950619 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950612 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950588 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950582 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950570 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950550 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950543 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950533 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950508 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153 THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950501 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950488 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950486 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00132, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950465 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00131, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER.

    Patient problems: No Patient Involvement

    MAUDE report 8950440 ↗
  • MalfunctionAug 30, 2019Material Deformation; Material Deformation

    RELATED MANUFACTURING REF: 2182269-2019-00132, 2182269-2019-00134, 2182269-2019-00135, 2182269-2019-00136, 2182269-2019-00137, 2182269-2019-00138, 2182269-2019-00140, 2182269-2019-00141, 2182269-2019-00142, 2182269-2019-00143, 2182269-2019-00144, 2182269-2019-00145, 2182269-2019-00146, 2182269-2019-00147, 2182269-2019-00148, 2182269-2019-00149, 2182269-2019-00150, 2182269-2019-00153. THIS REPORT IS TO ADVISE OF AN EVENT DURING ANALYSIS CONFIRMING THE CLEAR FILM OF THE GROUNDING PAD WAS ASSEMBLED ON THE INSIDE LAYER OF THE BLUE LINER WHICH MAY HAVE RESULTED IN THE REPORTED FIRST DEGREE BURN THAT OCCURRED DURING A LEFT CERVICAL ABLATION PROCEDURE.

    Patient problems: Superficial (First Degree) Burn

    MAUDE report 8950430 ↗
  • InjuryJun 25, 2019Material Separation; Material Separation

    FOLLOWING A 4-LEVEL UNILATERAL LUMBAR ABLATION PROCEDURE, A PATIENT BURN WAS NOTED AFTER REMOVING THE GROUNDING PAD. THE GROUNDING PAD HAD LEFT A CLEAR FILM ON THE PATIENT FOLLOWING REMOVAL AND A BLISTER WAS NOTED ON THE SKIN UNDER THE LEFT FLANK. THE PATIENTS SKIN WAS NOT PREPPED BEFORE PLACING THE GROUNDING PAD. NO TREATMENT WAS NEEDED TO TREAT THE BURN AND THE PATIENT IS IN STABLE CONDITION.

    Patient problems: Burn(s)

    MAUDE report 8730591 ↗
  • InjuryJun 25, 2019Material Separation; Material Separation

    FOLLOWING A 4-LEVEL UNILATERAL LUMBAR ABLATION PROCEDURE, A BURN WAS NOTED AFTER REMOVING THE GROUNDING PAD. THE GROUNDING PAD HAD LEFT A CLEAR FILM ON THE PATIENT FOLLOWING REMOVAL AND A BLISTER WAS NOTED ON THE SKIN UNDER THE LEFT FLANK. THE PATIENTS SKIN WAS NOT PREPPED BEFORE PLACING THE GROUNDING PAD. THE PATIENT IS IN STABLE CONDITION.

    Patient problems: Burn(s)

    MAUDE report 8730589 ↗

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