SAVI SCOUT® SSR75-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00852205006024), received between May 25, 2021 and May 19, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  "THE REPORTER ALLEGES THAT DURING AN EXCISIONAL BIOPSY PROCEDURE, THE ATTENDING PHYSICIAN WAS ADVISED OF A REFLECTOR'S LOCATION BY THE RADIOLOGIST. PRIOR TO PREPPING THE PATIENT, THE PHYSICIAN SURVEYED THE BREAST WITH A BACKUP GUIDE IN ATTEMPTS TO LOCATE THE REFLECTOR. SEVERAL BEEPS WERE RECEIVED REPEATEDLY. THE PHYSICIAN USED AN ULTRASOUND PROBE TO TRY AND LOCATE THE REFLECTOR BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO MAKE AN INCISION. THE GUIDE WAS PLACED WITHIN THE PATIENT'S BREAST, NO SIGNAL COULD BE HEARD. MOVING THE GUIDE AROUND, THE PHYSICIAN WAS EVENTUALLY ABLE TO HEAR A CADENCE, ON THE LEFT BREAST AT THE LOWER INNER QUADRANT. THE PHYSICIAN BEGAN FORMING A LARGE BALL WITH THE CUTTING BOVIE TO ENSURE THAT THE REFLECTOR WOULD BE REMOVED WITH THE SPECIMEN. ONCE THE SPECIMEN WAS OUT OF THE BODY, A CADENCE WAS HEARD. THE PHYSICIAN PLACED THE GUIDE BACK IN THE PATIENT AND HEARD A CADENCE IN A POSITION WHERE THERE WAS NO LONGER ANY BREAST TISSUE. THE PHYSICIAN REMOVED ANOTHER SPECIMEN FROM THE PATIENT BUT COULD NOT LOCATE THE REFLECTOR. THE PHYSICIAN PUT THE GUIDE BACK IN THE CAVITY WHERE THE SPECIMEN CAME OUT AND HEARD A STEADY CONSISTENT CADENCE. THE PHYSICIAN PLACED THE GU

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes

  MAUDE report 14438454 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 6, 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT RADAR. ONE EVENT ALLEGES THAT A PATIENT REQUIRED ASPIRATION OF AN AXILLARY SEROMA AFTER PLACEMENT OF A SCOUT REFLECTOR. STUDY: SROUR, MARISSA K., SUNGJIN KIM, FARIN AMERSI, ARMANDO E. GIULIANO, AND ALICE CHUNG. "COMPARISON OF WIRE LOCALIZATION, RADIOACTIVE SEED, AND SAVI SCOUT® RADAR FOR MANAGEMENT OF SURGICAL BREAST DISEASE." THE BREAST JOURNAL 26, NO. 3 (2020): 406-413.

  Patient problems: Seroma

  MAUDE report 12160297 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 6, 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT RADAR. ONE EVENT ALLEGES THAT A PATIENT REQUIRED INTERVENTION OF A HEMATOMA AFTER PLACEMENT OF A SCOUT REFLECTOR. STUDY: SROUR, MARISSA K., SUNGJIN KIM, FARIN AMERSI, ARMANDO E. GIULIANO, AND ALICE CHUNG. "COMPARISON OF WIRE LOCALIZATION, RADIOACTIVE SEED, AND SAVI SCOUT® RADAR FOR MANAGEMENT OF SURGICAL BREAST DISEASE." THE BREAST JOURNAL 26, NO. 3 (2020): 406-413.

  Patient problems: Hematoma

  MAUDE report 12160295 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 6, 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT RADAR. ONE EVENT ALLEGES THAT A PATIENT REQUIRED ASPIRATION OF AN AXILLARY SEROMA AFTER PLACEMENT OF A SCOUT REFLECTOR. STUDY: SROUR, MARISSA K., SUNGJIN KIM, FARIN AMERSI, ARMANDO E. GIULIANO, AND ALICE CHUNG. "COMPARISON OF WIRE LOCALIZATION, RADIOACTIVE SEED, AND SAVI SCOUT® RADAR FOR MANAGEMENT OF SURGICAL BREAST DISEASE." THE BREAST JOURNAL 26, NO. 3 (2020): 406-413.

  Patient problems: Seroma

  MAUDE report 12160293 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 6, 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY (SEE CITATION BELOW) REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT RADAR. ONE EVENT ALLEGES THAT A PATIENT DEVELOPED A MEDICAL COMPLICATION (APNEA, PACEMAKER, UTI) AFTER PLACEMENT OF A SCOUT REFLECTOR. THE STUDY DOES NOT SPECIFY WHICH COMPLICATION WAS DEVELOPED. STUDY: SROUR, MARISSA K., SUNGJIN KIM, FARIN AMERSI, ARMANDO E. GIULIANO, AND ALICE CHUNG. "COMPARISON OF WIRE LOCALIZATION, RADIOACTIVE SEED, AND SAVI SCOUT® RADAR FOR MANAGEMENT OF SURGICAL BREAST DISEASE." THE BREAST JOURNAL 26, NO. 3 (2020): 406-413.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12160292 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 6, 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY (SEE CITATION BELOW) REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT RADAR. ONE EVENT ALLEGES THAT A PATIENT DEVELOPED AN INFECTION AFTER PLACEMENT OF A SCOUT REFLECTOR. STUDY: SROUR, MARISSA K., SUNGJIN KIM, FARIN AMERSI, ARMANDO E. GIULIANO, AND ALICE CHUNG. "COMPARISON OF WIRE LOCALIZATION, RADIOACTIVE SEED, AND SAVI SCOUT® RADAR FOR MANAGEMENT OF SURGICAL BREAST DISEASE." THE BREAST JOURNAL 26, NO. 3 (2020): 406-413.

  Patient problems: Unspecified Infection

  MAUDE report 12160290 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 6, 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT RADAR. ONE EVENT ALLEGES THAT A PATIENT DEVELOPED AN INFECTION AFTER PLACEMENT OF A SCOUT REFLECTOR. STUDY: SROUR, MARISSA K., SUNGJIN KIM, FARIN AMERSI, ARMANDO E. GIULIANO, AND ALICE CHUNG. "COMPARISON OF WIRE LOCALIZATION, RADIOACTIVE SEED, AND SAVI SCOUT® RADAR FOR MANAGEMENT OF SURGICAL BREAST DISEASE." THE BREAST JOURNAL 26, NO. 3 (2020): 406-413.

  Patient problems: Unspecified Infection

  MAUDE report 12160289 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY (SEE CITATION BELOW) REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT SYSTEM. ONE EVENT ALLEGES THAT A PATIENT (ON FULL ANTICOAGULATION DUE TO FACTOR V LEIDEN GENOTYPE) DEVELOPED A PARTIAL WOUND DEHISCENCE AFTER PLACEMENT OF A SCOUT REFLECTOR AND USE OF THE SAVI SCOUT SYSTEM. THE WOUND WAS SUTURED UNDER LOCAL ANAESTHESIA IN THE OUTPATIENT SETTING. STUDY: TAYEH, SALIM, SAMANTHA MUKTAR, JENNIFER HEENEY, MICHAEL J. MICHELL, NICHOLAS PERRY, TAMARA SUARIS, DAVID EVANS, ANMOL MALHOTRA, AND KEFAH MOKBEL. "REFLECTOR-GUIDED LOCALIZATION OF NON-PALPABLE BREAST LESIONS: THE FIRST REPORTED EUROPEAN EVALUATION OF THE SAVI SCOUT® SYSTEM." ANTICANCER RESEARCH 40, NO. 7 (2020): 3915-3924.

  Patient problems: Wound Dehiscence

  MAUDE report 12160288 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT RADAR. ONE EVENT ALLEGES THAT A PATIENT DEVELOPED AN INFECTION AFTER PLACEMENT OF A SCOUT REFLECTOR. STUDY: SROUR, MARISSA K., SUNGJIN KIM, FARIN AMERSI, ARMANDO E. GIULIANO, AND ALICE CHUNG. "COMPARISON OF WIRE LOCALIZATION, RADIOACTIVE SEED, AND SAVI SCOUT® RADAR FOR MANAGEMENT OF SURGICAL BREAST DISEASE." THE BREAST JOURNAL 26, NO. 3 (2020): 406-413.

  Patient problems: Unspecified Infection

  MAUDE report 12160287 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON APRIL 6, 2021, A MERIT EMPLOYEE CONDUCTED A CER LITERATURE SEARCH FOR THE SCOUT PRODUCT FAMILY. THE STUDY (SEE CITATION BELOW) REPORTS ADVERSE EVENTS RELATED TO THE SAVI SCOUT SYSTEM. ONE EVENT ALLEGES THAT A PATIENT DEVELOPED A POSTOPERATIVE HAEMATOMA THAT REQUIRED SURGICAL EVACUATION AFTER PLACEMENT OF A SCOUT REFLECTOR AND USE OF THE SAVI SCOUT SYSTEM. STUDY: TAYEH, SALIM, SAMANTHA MUKTAR, JENNIFER HEENEY, MICHAEL J. MICHELL, NICHOLAS PERRY, TAMARA SUARIS, DAVID EVANS, ANMOL MALHOTRA, AND KEFAH MOKBEL. "REFLECTOR-GUIDED LOCALIZATION OF NON-PALPABLE BREAST LESIONS: THE FIRST REPORTED EUROPEAN EVALUATION OF THE SAVI SCOUT® SYSTEM." ANTICANCER RESEARCH 40, NO. 7 (2020): 3915-3924.

  Patient problems: Hematoma

  MAUDE report 12160286 ↗
• InjuryMay 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ACCOUNT ALLEGES THAT THE PATIENT REPORTED FULL BODY HIVES AFTER 2 REFLECTORS WERE PLACED BY PROVIDER. PATIENT WAS DIRECTED TO GO TO ER FOR IV STEROIDS AND WAS SENT TO SURGERY WITH BOTH REFLECTORS REMOVED SUCCESSFULLY. PATIENT HAS NO KNOWN ALLERGIES. PATIENT HAS IMPROVED WITH PLANS TO BE EVALUATED FOR ALLERGY SENSITIVITY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11881991 ↗