PIPELINE 287105015Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034217604), received between Jan 3, 2020 and Nov 14, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON WAS COMPLETING A COMBINED CASE WITH BOTH VIPER PRIME AND EXPEDIUM. THE PATIENT HAD VERY HARD BONE AND DURING THE PROCESS, TWO VIPER PRIME DILATOR HOLDERS WERE DAMAGED AT THE DISTAL END TIP AS WELL AS THE POLYAXIAL SCREWDRIVER TIP BROKE (THE SCREW WAS REMOVED) AND THE TORQUE DRIVE WAS STRIPPED. THERE WERE NO PATIENT CONSEQUENCES, NO PATIENT INFO WAS COLLECTED AND THERE WAS NO DELAY. NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688768 ↗
• MalfunctionNov 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON WAS COMPLETING A COMBINED CASE WITH BOTH VIPER PRIME AND EXPEDIUM. THE PATIENT HAD VERY HARD BONE AND DURING THE PROCESS, TWO VIPER PRIME DILATOR HOLDERS WERE DAMAGED AT THE DISTAL END TIP AS WELL AS THE POLYAXIAL SCREWDRIVER TIP BROKE (THE SCREW WAS REMOVED) AND THE TORQUE DRIVE WAS STRIPPED. THERE WERE NO PATIENT CONSEQUENCES, NO PATIENT INFO WAS COLLECTED AND THERE WAS NO DELAY. NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678877 ↗
• MalfunctionAug 29, 2024Contamination /Decontamination Problem; Material Twisted/Bent; Contamination /Decontamination Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE HOLDER FOR THE VIPER PRIME SET WAS DISCOVERED TO HAVE THE SILICONE TIPS STRIPPED AND THE UNDERLYING METAL EXPOSED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PIPELINE LS DILATOR HOLDER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20101845 ↗
• MalfunctionJan 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE WAS NO PATIENT HARM AND NO DELAYED SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243971 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NOTICED THAT THE PALM HANDLES WERE DAMAGED ON THE TOP. ONCE THE HANDLE WAS INSERTED, THE GAUGE COULD NOT BE EASILY INSERTED DUE TO THE DAMAGED METAL ON THE TOP OF THE PALM HANDLE. ALSO, THE TARGETING FORCEPS WERE OLD AND DAMAGED AT THE TIP, WHERE THE BLACK RUBBER MATERIAL IS WEARING OFF AND STARTING TO PEEL. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THESE EVENTS. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE PIPELINE LS ACCESS SYSTEM DILATOR HOLDER. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15618287 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON SEPTEMBER 26, 2022, IT WAS NOTICED THAT THE PALM HANDLES WERE DAMAGED ON THE TOP. ONCE THE HANDLE WAS INSERTED, THE GAUGE COULD NOT BE EASILY INSERTED DUE TO THE DAMAGED METAL ON THE TOP OF THE PALM HANDLE. ALSO, THE TARGETING FORCEPS WERE OLD AND DAMAGED AT THE TIP, WHERE THE BLACK RUBBER MATERIAL IS WEARING OFF AND STARTING TO PEEL. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THESE EVENTS. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE PIPELINE LS ACCESS SYSTEM DILATOR HOLDER. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617996 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NOTICED THAT THE PALM HANDLES WERE DAMAGED ON THE TOP. ONCE THE HANDLE WAS INSERTED, THE GAUGE COULD NOT BE EASILY INSERTED DUE TO THE DAMAGED METAL ON THE TOP OF THE PALM HANDLE. ALSO, THE TARGETING FORCEPS WERE OLD AND DAMAGED AT THE TIP, WHERE THE BLACK RUBBER MATERIAL IS WEARING OFF AND STARTING TO PEEL. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THESE EVENTS. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE PIPELINE LS ACCESS SYSTEM DILATOR HOLDER. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617974 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS NOTICED THAT THE PALM HANDLES WERE DAMAGED ON THE TOP. ONCE THE HANDLE WAS INSERTED, THE GAUGE COULD NOT BE EASILY INSERTED DUE TO THE DAMAGED METAL ON THE TOP OF THE PALM HANDLE. ALSO, THE TARGETING FORCEPS WERE OLD AND DAMAGED AT THE TIP, WHERE THE BLACK RUBBER MATERIAL IS WEARING OFF AND STARTING TO PEEL. THERE WAS NO PATIENT CONSEQUENCE AS A RESULT OF THESE EVENTS. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE PIPELINE LS ACCESS SYSTEM DILATOR HOLDER. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617811 ↗
• MalfunctionMay 4, 2021Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE STERILIZATION PROCESS, IT WAS NOTICED THAT THE RUBBER INSULATION OF THE CLAMP IS NO LONGER COMPLETE. THERE WAS A PIECE IS MISSING. IT WAS NOT CLEAR WHETHER THE PIECE OF RUBBER FELL OFF DURING THE SURGERY. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) PIPELINE LS DILATOR HOLDER. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773536 ↗
• MalfunctionJan 3, 2020Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A PIPELINE LS DILATOR HOLDER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A PIPELINE LS DILATOR HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547876 ↗