Drive System (Straub Medical®) Version 1.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07640142810889), received between Aug 25, 2022 and Jul 3, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (17 reports).

1 other recall cover devices cleared under the same FDA submission (K172315); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Break; Self-Activation or Keying; Power Problem; Intermittent Loss of Power; Incomplete or Inadequate Connection; Break; Self-Activation or Keying; Power Problem; Intermittent Loss of Power; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT PRIOR TO A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE DEVICE HAS NO KNOWN ISSUE. IT WAS FURTHER REPORTED THAT HOWEVER, AFTER EVALUATION AT THE SERVICE CENTER, IT WAS FOUND THAT THE DEVICE FOOT SWITCH WAS ALLEGEDLY ACTIVATED ON ITS OWN, THE FOOT SWITCH WAS ALLEGEDLY DIFFICULT TO UNPLUG, AND THE MOTOR WIRE WAS ALLEGEDLY LOOSENED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19672694 ↗
• MalfunctionNov 24, 2022Device Difficult to Setup or Prepare; Device Markings/Labelling Problem; Inaccurate Information; Device Difficult to Setup or Prepare; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO THE RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INCORRECT SERIAL NUMBER ON THE EXTERNAL PACKAGING AND DID NOT MATCH THE DEVICE IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860537 ↗
• MalfunctionNov 24, 2022Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO THE RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INCORRECT SERIAL NUMBER ON THE EXTERNAL PACKAGING AND DID NOT MATCH THE DEVICE IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860429 ↗
• MalfunctionNov 24, 2022Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO THE RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INCORRECT SERIAL NUMBER ON THE EXTERNAL PACKAGING AND DID NOT MATCH THE DEVICE IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859960 ↗
• MalfunctionNov 23, 2022Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO THE RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INCORRECT SERIAL NUMBER ON THE EXTERNAL PACKAGING AND DID NOT MATCH THE DEVICE IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850768 ↗
• MalfunctionNov 23, 2022Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO THE RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INCORRECT SERIAL NUMBER ON THE EXTERNAL PACKAGING AND DID NOT MATCH THE DEVICE IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850740 ↗
• MalfunctionNov 23, 2022Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO THE RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD AN INCORRECT SERIAL NUMBER ON THE EXTERNAL PACKAGING AND DID NOT MATCH THE DEVICE IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850709 ↗
• MalfunctionSep 9, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15389515 ↗
• MalfunctionSep 9, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15389186 ↗
• MalfunctionSep 8, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378093 ↗
• MalfunctionSep 8, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378092 ↗
• MalfunctionSep 8, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15377335 ↗
• MalfunctionSep 7, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED IN A BOX WITH AN INCORRECT LABEL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369729 ↗
• MalfunctionSep 7, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369463 ↗
• MalfunctionSep 7, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369462 ↗
• MalfunctionSep 3, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS PACKED WITH EXTERNAL PACKAGING LABELED WITH THE INCORRECT SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353535 ↗
• MalfunctionAug 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE INCORRECT SERIAL NUMBER WAS ON THE EXTERNAL PACKAGING AND DID NOT MATCH THE DEVICE IN THE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291467 ↗
• MalfunctionAug 25, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE DEVICE WAS RECEIVED WITH EXTERNAL PACKAGING LABELED WITH SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172315. One submission often covers many models, so check the product and lot details in each record.

• Z-1244-2025 · Feb 5, 2025 · Open, Classified
  Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239