PINNACLE RSS601Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00389701007250), received between Oct 26, 2017 and Jan 26, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2023Break; Difficult to Remove; Physical Resistance/Sticking; Break; Difficult to Remove; Physical Resistance/Sticking

  A MAUDE DATABASE SEARCH CONDUCTED ON 31 MAR 2023 FOUND A MAUDE REPORT NUMBER (B)(4). THE EVENT DESCRIPTION STATES: "6F SHEATH WAS PLACED IN FEMORAL ARTERY. BLEEDING WAS NOTED PRIOR TO CLOSURE, AND PHYSICIAN DETERMINED TO REMOVE SHEATH AND REPLACE WITH A 7F. UPON REMOVAL OF 6F SHEATH, THE PROXIMAL PART OF SHEATH WAS REMOVED, BUT THE DISTAL PART OF SHEATH BROKE OFF AND WAS LEFT INSIDE THE PATIENT. PATIENT REQUIRED BLOOD PRODUCT, ANESTHESIA, AND EMERGENT CUT DOWN AND REMOVAL OF THE DISTAL PIECE OF SHEATH FROM FEMORAL ARTERY. MANUFACTURER RESPONSE FOR (B)(4) (PER SITE REPORTER). NO RESPONSE TO DATE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16247086 ↗
• MalfunctionJan 26, 2023Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT THE 6FR PINNACLE SHEATH SEEMED TO BE TIGHT AND RESTRICTIVE TO THE 6F CATHETER THAT WAS USED WITH IT DURING THE CASE. THE PATIENT WAS STABLE, AND THE OUTCOME OF THE PROCEDURE WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 30 DEC 2022: THE PROCEDURE WAS A CORONARY ANGIOPLASTY. PROCEDURE WAS COMPLETED USING THE SHEATH, IT WAS JUST VERY TIGHT TRYING TO ADVANCE AND MANIPULATE THE CATHETER THROUGH THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245818 ↗
• InjuryApr 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT FLUOROSCOPY REVEALED PART OF THE NON-ABBOTT 6FR SHEATH WAS IDENTIFIED FLOATING IN THE RIGHT ATRIUM. A SNARE RETRIEVAL SYSTEM (UNKNOWN MANUFACTURER) WAS INTRODUCED, AND THE PARTIAL SHEATH WAS RETRIEVED FROM THE PULMONARY ARTERY (WHICH IS WHERE THE SHEATH HAD ADVANCED TO AT THAT POINT). FOLLOWING REMOVAL, ALL DIAGNOSTIC CATHETERS WERE INTACT, AND THE PHYSICIAN LEFT THE ROOM. THEN, THE OPERATING PHYSICIAN TRIED TO INTRODUCE A NEW NON-ABBOTT 8F SHEATH INTO THE GROIN, AT WHICH IT WAS OBSERVED THAT THIS NEW SHEATH ALSO WAS SEVERED AND LEFT A PARTIAL SEGMENT INSIDE THE RIGHT FEMORAL VEIN. THE OTHER PHYSICIAN WAS NOTIFIED AND CAME BACK AND USED ANOTHER SNARE RETRIEVAL SYSTEM (MANUFACTURER UNKNOWN) FROM THE LEFT GROIN TO RETRIEVE THE 8F SEGMENT FROM THE RIGHT SIDE. THERE WAS SUCCESSFUL RETRIEVAL OF SAID SHEATH SEGMENT AND THE REST OF THE CIRCULATORY SYSTEM OF PATIENT WAS OBSERVED UNDER FLUOROSCOPY TO MAKE SURE THAT THERE WERE NO REMAINING FRAGMENTS/SEGMENTS OF SHEATH IN THE BODY. THE PROCEDURE WAS THEN ABORTED, AND ALL REMAINING SHEATHS REMOVED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE WITH NO COMPLICATIONS OR ADVERSE EVENTS/OUTCOMES. ADDITIONAL INFORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136162 ↗
• InjuryOct 3, 2018Break; Break

  THE USER FACILITY REPORTED THAT THE PATIENT HAD AN A-FIB ABLATION, WITH LEFT FEMORAL VEIN ACCESS USING A RADIFOCUS INTRODUCER II KIT. AFTER THE PROCEDURE AND DURING SHEATH REMOVAL, THE SHEATH SEPARATED FROM THE HUB. IT WAS NOT A CLEAN BREAK. THE DOCTOR HAD TO REMOVE THE REMAINING BODY OF THE SHEATH BY DOING AN INCISION AND REMOVING WITH A KELLY CLAMP. THE PATIENT WAS STABLE AT THE END OF THE SHEATH REMOVAL. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 9/21/18: THE REPORTED BLOOD LOSS WAS ESTIMATED TO BE 10 CC.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 7929602 ↗
• MalfunctionOct 26, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAK WITH THE INVOLVED PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE VALVE WAS LEAKING; BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC; PATIENT WAS REPORTED TO BE STABLE; AND THE PROCEDURE OUTCOME WAS FINE AND SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 4, 2017. A CATHETER WAS USED WITH REPORTED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6980933 ↗